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Development Resource Group

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Category : Electrical Engineer
Job Type : Contract
Id : 8551
Region : Twin Cities

Seeking an entry level Electrical Engineer that has experience troubleshooting and failure analysis of electronic circuits, both analogue and digital. This engineer must have an understanding of schematics and how the components of a circuit function. Should be proficient in Word, Powerpoint, Excel, and Access. Must have the knowledge of the common failure modes of electronic components and assemblies; ability to design, build, and assemble prototype circuits for test fixtures; and document quality issues and performance measures for management review. May liaise with external vendors.

Experience: 0-3 years

Education: Bachelor's degree in Electrical Engineering



Posted: November 30, 2021, 7:04 am
Category : Mechanical Designer
Job Type : Contract
Id : 8549
Region : Twin Cities

The Mechanical Designer will be responsible for design of special machines, fixtures, and automated production equipment.

Prefer a 2 year degree in mechanical design and 5 to 10+ years of hands on automated equipment design experience, from concept through detailed design.

Requirements include strong SolidWorks design skills, and experience in one or more of the following areas: product packaging or assembly equipment, dial and indexing systems, robotics and motion control for manufacturing equipment. Ability to specify components, drives, material handling systems, pneumatics, and related automation components is required, and experience with medical / pharmaceutical equipment design preferred.




Posted: November 22, 2021, 9:49 am
Category : Controls Engineer
Job Type : Permanent
Id : 8543
Region : Twin Cities

Seeking an Automation Engineer for the following:

  • Develop, install, and integrate new robotic equipment.
  • Evaluate automation needs to improve production flow.
  • Continuous Improvement of machinery or production process.
  • Basic robot, PLC programming and electrical troubleshooting.
  • Working on troubleshooting machines. Must be able to take a machine apart and put it back together.
  • Strong verbal & written communication skills including the ability to write technical specifications, design documentation and verification test plans & reports.
  • Complete projects within budgetary and scheduling goals.

Required education and/or experience:

Successful candidates for this role have experience designing and coordinating automation, fabrication and build activities for new automation opportunities to ensure products and systems meet expectations, work to resolve technical issues, and developing design proposals, specifications, and documentation.

To be considered for this opportunity, you must have a Bachelor's degree in Mechanical Engineering or equivalent from four-year college or university; or one to two years related experience and/or training; or equivalent combination of education and experience. Minimum 3+ years of experience preferred in new product development. Direct experience with the product development process ranging from requirements development, prototyping, verification and product release is preferred. Must have demonstrated experience working on automation systems.



Posted: November 17, 2021, 11:33 am
Category : Technical Writer
Job Type : Contract
Id : 8544
Region : Twin Cities

The Engineering Technical writer creates, develops, plans, writes and edits operational, instructional, maintenance or test procedures for paper, multimedia, web-based publications and user sites; may produce content for embedded user assistance technology. Conducts interviews with various users and technical staff to gather data for documentation. Researches and translates technical information into manuals and/or web-based documents for nontechnical and technical users. May document engineering processes and specifications. Recommends formats responsive to technical and customer requirements. Produces products that conform to the company documentation and quality assurance standards.

Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University).

Autonomy: Established and productive individual contributor. Works independently with general supervision on larger, moderately complex projects / assignments.

Organizational Impact: Sets objectives for own job area to meet the objectives of projects and assignments. Contributes to the completion of project milestones. May have some involvement in cross functional assignments.

Innovation and Complexity: Problems and issues faced are general, and may require understanding of broader set of issues or other job areas but typically are not complex. Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area.

Communication and Influence: Communicates primarily and frequently with internal contacts. External interactions are less complex or problem solving in nature. Contacts others to share information, status, needs and issues in order to inform, gain input, and support decision making.

Leadership and Talent Management: May provide guidance and assistance to entry level professionals and / or employee in Support Career Stream.

Required Knowledge and Experience: Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience. Requires a University Degree and minimum of 2 years of relevant experience, or advanced degree with 0 years of experience.



Posted: November 16, 2021, 9:47 am
Category : Quality/Regulatory
Job Type : Contract
Id : 8542
Region : Twin Cities

The Associate Quality Engineer develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product. Collaborates with engineering and manufacturing functions to ensure quality standards are in place. Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment. Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications. Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements. May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.

Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University).

  • Autonomy: Entry-level individual contributor on a project or work team. Works with close supervision.
  • Organizational Impact: Delivers work of limited scope, typically smaller, less complex projects or related activities.
  • Innovation and Complexity: Identifies, defines and addresses problems that are not immediately evident but typically not difficult or complex. Makes minor changes in systems and processes to solve problems.
  • Communication and Influence: Communicates primarily with internal contacts within immediate group. Contacts others to gather, confirm and convey information.
  • Required Knowledge and Experience: Requires broad theoretical job knowledge typically obtained through advanced education. Requires a University Degree, 0 years of experience required.


Posted: November 16, 2021, 8:27 am
Category : Hardware Engineer
Job Type : Contract
Id : 8541
Region : Twin Cities

The Sr. Hardware Engineer conducts research, design, development, and testing of electrical or mechanical hardware such as computer chips, circuit boards, mechanical and electrical components. Ensures reliability, develops technical specifications for production, analyzes hardware configuration and processing solutions, and tests hardware conformance to specifications; may design new or modify existing products.

Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University).

  • Autonomy: Seasoned individual contributor. Works independently under limited supervision to determine and develop approach to solutions. Coaches and reviews the work of lower level specialists; may manage projects / processes.
  • Organizational Impact: May be responsible for entire projects or processes within job area. Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments.
  • Innovation and Complexity: Problems and issues faced are difficult, and may require understanding of multiple issues, job areas or specialties. Makes improvements of processes, systems or products to enhance performance of the job area. Analysis provided is in-depth in nature and often provides recommendations on process improvements.
  • Communication and Influence: Communicates with senior internal and external customers and vendors. Exchange information of facts, statuses, ideas and issues to achieve objective, and influence decision making.
  • Leadership and Talent Management: May provide guidance, coaching and training to other employees within job area. May manage projects, requiring delegation of work and review of others' work product.
  • Required Knowledge and Experience: Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience. May have practical knowledge of project management. Requires a University Degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.


Posted: November 15, 2021, 6:27 am
Category : Mechanical Engineer
Job Type : Permanent
Id : 8540
Region : Twin Cities

The Mechanical Design Engineer is responsible for the development of the precision alignment equipment that produces sensors. This includes concept design, detail design, testing, documenting, and transferring the design into production.

Core Responsibilities:

  • Mechanical design of precision alignment equipment
  • Design of custom machined and sheet metal parts
  • Design opto-mechanical mounts to provide precise alignment, adjustment, and robustness to meet critical optical performance requirements
  • Selection and integration of precision motion
  • Design for operator ease of use, human factors, and safety
  • Communicate with internal customers to define requirements
  • Collaborate with production on design manufacturability
  • Consult with manufacturing partners on part fabrication
  • Assemble and test final hardware
  • Create product drawings and project documents
  • Transition new designs to production and support existing production

Experience, Education and Competencies Required:

  • 3+ years of experience designing precision processing equipment, inspection equipment, precision equipment, sensors, or electro-mechanical instruments
  • Experience as a mechanical design engineer, designing custom machined and fabricated parts
  • B.S. degree in Mechanical Engineering, or equivalent field
  • Proficient in mechanical CAD (Pro/Engineer preferred) and exposure to CAD data management
  • Experience/knowledge of manufacturing processes especially machining and low volume sheet metal.
  • Experience in a structured development process from requirements definition, to concept design, to detail design, to testing, and implementation into production
  • Experience in, or ability to learn, operating a mill and lathe for part modification and fabrication
  • Must work well in teams with other Engineering disciplines, including Electrical, Optical, Software, and Manufacturing
  • Good interpersonal skills. Good oral and written communications.

Experience, Education and Competencies Preferred:

  • Mechanical design of precision sensors
  • Design of opto-mechanical assemblies a plus


Posted: November 12, 2021, 1:18 pm
Category : Manufacturing Engineer
Job Type : Contract
Id : 8538
Region : Twin Cities

Seeking a Manufacturing Engineer to work closely with Operations, Quality and the Laboratory to improve existing manufacturing processes that produce products of the highest quality and reliability for a major medical device company.

A Day in the life:

  • Support the production line including troubleshooting and continuous improvement projects
  • Work effectively in cross-functional project teams and work independently to accomplish project goals.
  • Follow established procedures to perform and participate in improvement initiatives for detailed, accurate, and compliant engineering documentation
  • Navigate through current state, trouble shoot; determine root cause and actions to address issues.
  • Partner with Quality, Laboratory and Operations and utilize COS/ lean/Six Sigma principles to create technical solutions for product assembly that are consistent with organization objectives.

Must Have:

  • Bachelor’s degree in a relevant field
  • Minimum of 1 years’ experience in operations/process engineering

Nice to Have:

  • Knowledge of Good Manufacturing Practices (GMP) and applicable Quality System Standards.
  • Experience handling multiple tasks concurrently
  • Excellent data analysis skills and proficient in the use of statistical tools in problem solving
  • Knowledge of quality systems
  • Experience with Medical Device Regulation
  • Experience in medical product manufacturing / assembly operations
  • Experience interpreting mechanical drawings
  • Equipment and process validation (IQ, OQ, PQ)
  • Experience with CAPAs, root cause analysis
  • Six Sigma DMAIC training


Posted: November 10, 2021, 11:09 am
Category : Software Engineer
Job Type : Contract
Id : 8537
Region : Twin Cities

Seeking a Senior Software Test Engineer to join our R&D Organization to develop and test new and modifications to embedded software for cardiac ablation systems. The Senior Software Test Engineer will also be responsible for designing automated test systems or subsystems for testing the equipment.

Areas of responsibilities will include embedded software test system design, design requirements, test requirements, test procedures, PC-based simulation and test automation in C#. Candidates must be able to generate and review interface specifications, test specifications and test reports in compliance with design control procedures used within the medical device industry. Candidates must also be willing to work in a fast paced, multi-tasking, team environment.

POSITION RESPONSIBILITIES

  • Effectively work with a variety of individuals ranging from various engineering disciplines (software, firmware, electrical, mechanical, systems) to reliability, regulatory and operations.
  • Test, document, operate and maintain software/firmware components and computing systems software to be applied to and integrated with mechanical and electrical systems.
  • Apply the appropriate standards, processes, procedures and tools throughout the system development life cycle to support the generation of such engineering applications and wide range of products.
  • Support Manufacturing in troubleshooting operations involving medical devices through assembly and test
  • Research and implement new technologies to enhance product features, improve reliability, and lower cost
  • Provide technical assistance to other functional departments such as Quality, Reliability, and Manufacturing
  • Work in an Agile environment as part of team, in consultation with Engineering Management and project leaders.

BASIC QUALIFICATIONS/EDUCATION/EXPERIENCE

  • 5+ years of embedded testing and/or development experience with Bachelors Degree in Engineering (Computer Science, Software, Biomedical, or Electrical preferred), or 3+ years of experience with additional advanced degree.
  • 1+ years of direct embedded testing experience.
  • Strong experience working with hardware, including ability to read schematics, data sheets and interface specifications
  • Strong experience in technical specification, traceability analysis, and report writing
  • Ability to work with minimal supervision
  • Ability to work in a multi-site team environment displaying strong collaboration skills
  • Excellent written and oral communication skills, including the ability to clearly and concisely summarize complex technical concepts and problems.

DESIRED/PREFERRED QUALIFICATIONS

  • Experience using Microsoft Visual Studio and Test Manager
  • Experience developing test software and automation with C# language and .NET framework
  • Experience with TCP/IP communication
  • Experience with CAN bus communication
  • Experience with security techniques and protocols
  • Experience with ARM Cortex M processors (preferably STMicro)
  • Experience with real-time operating system (e.g. µC/OS-II, FreeRTOS)
  • Experience with cardiac ablation product
  • Specific knowledge of international medical device standards


Posted: November 9, 2021, 6:23 am
Category : R&D Engineer
Job Type : Contract
Id : 8536
Region : Twin Cities

Seeking an R&D Engineer with EU-MDR Experience to work on cardiac surgery and transcatheter heart valve remediation and continuous improvement activities for a major medical device company.

 

Position Responsibilities:

  • Perform, summarize and present research to assist the team in meeting project requirements
  • Participate in or lead problem-solving investigations
  • Develop or improve test methods utilizing skill sets including mechanical design, prototyping, problem solving and measurement systems analysis
  • Work with cross-functional teams to establish the device lifetime for each product
  • Support materials compliance teams with BOM, identification and verification of patient contacting and invasive component list
  • Updates to DHF, design inputs/outputs and product specification as applicable (from detailed gap assessment)
  • Update CAD files, design prints as necessary (materials compliance)
  • Support design quality engineers with risk management updates (frequency of occurrence and assessment of risks)
  • Ensure biocompatibility documentation is complete, update as necessary with shared biocompatibility services
  • Execute V&V work (to current standards as applicable)
  • Support inputs for General Safety and Performance Requirements (GSPR)

 

Requirements:

  • Bachelors degree
  • 1-5 years' experience
  • Familiar with design controls and implantable devices
  • Continuous improvement / sustaining engineering experience
  • Previous work on U.S. class II or class III devices, class III preferred
  • Design assurance / development quality experience a plus
  • Experience working with tissue a plus
  • Experience working with heart valves a plus
  • Working knowledge of the E.U. medical device regulation a plus


Posted: November 8, 2021, 11:47 am
Category : Quality/Regulatory
Job Type : Contract
Id : 8535
Region : Twin Cities

We are seeking an experienced Design Assurance Engineer to join our Structural Heart Development Quality team in our Saint Paul, MN site. The individual in this position will assure new or modified products conform to requirements and establish compliance with the quality system. This position is responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient/user safety and meeting business needs. This position will support new product development projects and lead completion of design control deliverables, such as design verification, design validation and risk management.

Primary Duties and Responsibilities:

  • Participate in or lead teams in supporting quality disciplines, decisions, and practices (e.g., represent the Design Quality function as a Core Team Member)
  • Lead on-time completion of Design Control Deliverables
  • Create and ensure on-time execution of Quality Plans for internal development, OEM-based, Clinical Product Development (CPDP), and design change projects
  • Accountable for Design Verification and Validation planning and execution, including active cross-functional root-cause analysis investigation and resolution activities
  • Lead or support Risk Management activities, including analyzing field data to support new product development, supporting Failure Mode Effects Analysis, generation of risk management plans/reports, and completion of hazard analysis
  • Support design test and inspection method development, and lead test method validation activities
  • Ensure Device History File (DHF) content completion, integrity, and regulatory & standards compliance; collaboratively identifying, communicating, and resolving gaps
  • Support manufacturing process development and qualification for new product commercialization and product changes
  • Support internal and external audit responses and on-time product re-certifications
  • Support and ensure the establishment of objective, measurable, discrete, and verifiable customer and product requirements
  • Support and ensure objective component specification definitions
  • Support the development and review of biocompatibility and sterilization validations
  • Supports R&D product builds for bench testing, animal lab, and first in human activities.
  • Complete Document Change Request Reviews in a timely and objective manner
  • Participates in Corrective Action/Preventive Action (CAPA) process including the investigation of failures or deviations, as required.
  • Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
  • Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments
  • Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors

Other Duties:

  • Additional duties may be identified by functional management based on the current project/business objectives.
  • Support all Divisional initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements

Required Qualifications:

  • Bachelor’s degree within an Engineering field or related science-based discipline
  • 2-5 years of related work experience
  • Previous Quality engineering experience and demonstrated use of Quality tools/methodologies
  • Solid verbal, written, and interpersonal skills with ability to effectively communicate at multiple levels in the organization
  • Ability to work in a highly matrixed and geographically diverse business environment.
  • Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
  • Ability to leverage and/or engage others to accomplish projects.
  • Multitasks, prioritizes, and meets deadlines in timely manner.
  • Strong organizational and follow-up skills, as well as attention to detail.
  • Ability to travel up to 10%.
  • This is not a work from home position

Preferred Qualifications:

  • Advanced degree in a technical field
  • Medical device experience, specifically with heart valves and /or implantable devices
  • Experience working in a broader enterprise/cross-division business unit model
  • Prior experience working with any or all of the following:
  • ISO 13485 Medical Devices – Quality Management System
  • 21 CFR Part 820 FDA Quality System Regulations
  • ISO 14971 Medical Devices – Application of Risk Management
  • EUMDR
  • MDSAP
  • Good Manufacturing Practices and Good Documentation Practices


Posted: November 8, 2021, 11:37 am
Category : R&D Engineer
Job Type : Contract
Id : 8534
Region : Twin Cities

Seeking an R&D Engineer Responsible for coordinating all activities necessary to complete Human Factors engineering projects. Activities include, but are not limited to:

  • Conducting ethnographic user research to identify user needs
  • Translating user needs to requirements and product design concepts
  • Developing prototypes to explore and validate product design concepts
  • Performing workflow, task and use error analyses
  • Conducting Formative Usability testing
  • Conducting Summative Validation testing
  • Participate on development program teams to ensure human factors principles are considered and implemented.
  • Organize and direct the work of outside consultants working on human factors tasks to effectively and efficiently support product development efforts within the organization.
  • Create and communicate project plans and deliverables, and manage time to meet project deadlines.

Your Experience and Skillsets:

  • Proven ability to apply knowledge of Human Factors principles (human performance and limitations – perceptual, cognitive, motor skills, anthropomorphic) and techniques (user research, user-interface design, usability testing) to the design, development, and evaluation of hardware and/or software products.
  • Experience leading Human Factors activities across the product lifecycle, including ethnographic research, user needs identification, workflow and task analysis, requirements development, user interface design, user error analysis, usability and validation testing.
  • Proven ability to work with cross-functional teams and provide technical leadership.
  • Experience with software and/or hardware user-interface design.
  • Proven ability to interface with customers in a highly professional manner.
  • Ability to quickly assimilate advanced domain knowledge.
  • Excellent verbal and written communication and presentation skills.

Education Requirements:

  • M.S. degree in Human Factors Engineering, Design, Cognitive Psychology, Anthropology, Human-Computer Interaction or a related discipline.
  • Minimum 3+ years of relevant Human Factors/Usability engineering experience in hardware-software systems product development.

Your Preferred Qualifications and Education:

  • Ph.D. degree in one of the above disciplines.
  • Experience in medical device development.
  • Working knowledge of cardiac electrophysiology.
  • Working knowledge of Human Factors/Usability Engineering regulatory standards.


Posted: November 5, 2021, 7:33 am
Category : Electrical Engineer
Job Type : Contract
Id : 8533
Region : Twin Cities

Seeking an Electrical Engineer II to assist the WP Team with the following…

  • Creating test plans, collecting test data, analyzing results, writing engineering reports
  • Designing schematics and layout for prototyping
  • Developing test code for test fixtures
  • Supporting lab infrastructure and PCB database library – ECAD maintenance and management
  • Creating and reviewing schematic symbols and component footprints
  • Maintains detailed documentation throughout all phases of research and development.
  • Resolves and/or facilitates the resolution of complex technical problems including identifying root causes to prevent re-occurrence.
  • Validates equipment and processes as required.
  • Conducts evaluations, tests and analyses related to feasibility and function.
  • Writes technical reports and conducts presentations to document work, illustrate concepts and demonstrate progress.
  • Conducts measurements specified in design verification plans, documents and tabulates results, and provides engineering test reports.
  • Ensures compliance with procedural and documentation requirements of Company, FDA and ISO design controls.
  • Assists with all safety and EMC testing on the IEC 60601 family of standards.
  • Conceptualizes new designs using technical expertise and innovative approaches.
  • Supports animal studies, bench testing, clinical evaluations, and production.
  • Establishes test methods and model development.
  • Documents activities, including designs and design concepts, to support successful project transfers from research to product development programs.
  • Support all company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.

Required

  • Bachelor’s degree in Electrical/Electronic Engineering or other related Engineering field
  • At least 2-5 years of relevant analog and digital design work experience in performing the schematic capture, layout, construction, test, and evaluation of a variety of prototype Printed Circuit Assemblies, fixtures and tools.
  • Solid fundamental understanding of analog and digital circuits
  • A solid understanding of high-speed signal integrity and EMI mitigation techniques.
  • Knowledge of schematic and layout PCB tools
  • Soldering and de soldering techniques and ability to assemble prototype boards
  • Strong verbal and written communication with good organizational skills and ability to multi-task
  • Ability to take initiative and work independently
  • Strong ability to work effectively within a cross-functional product development team.
  • Strong written communication skills with ability to work within a quality management system utilizing design controls.
  • Ability to solve a variety of complex problems of diverse scope.
  • Proficiency with measurement techniques and concepts relevant to RF applications (e.g. VNA measurements, impedance matching, transmission line theory, etc.)

Preferred

  • Medical Device experience
  • Familiarity with IEC 60601 family of standards
  • Experience with PCB schematic and layout design tools such as Altium.
  • Demonstrated ability to develop completely new designs and new design features as part of existing systems.
  • Demonstrated ability to learn new skills quickly and perform developed skills with a high level of quality.
  • Documented record of identifying and delivering key engineering information which adds value to management’s decision-making process.
  • Experience working in a broader enterprise/cross-division business unit model preferred.
  • Experience with FPGA hardware design and HDL programming such as Verilog.
  • Ability to work in a highly matrixed and geographically diverse business environment.
  • Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
  • Ability to leverage and/or engage others to accomplish projects.
  • Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
  • Multitasks, prioritizes and meets deadlines in an effective manner.
  • Strong organizational and follow-up skills, as well as attention to detail.


Posted: November 4, 2021, 11:24 am
Category : Firmware Engineer
Job Type : Contract
Id : 8532
Region : Twin Cities

Seeking an Embedded Software Engineer working under general supervision, performs specialized level software project activities in such areas as Development, Tools, Test, Requirements and/or related areas. Assignments may include, but are not limited to, analyzing requirements, planning and scheduling data, updating and maintaining different software specifications based on analysis of specifications, needs and improvements, as well as troubleshooting, debugging, and maintaining of software, test, or tool designs, cases, scripts, procedures, and/or code based on strategic analysis. Work requires the application of theoretical engineering principles, evaluation, ingenuity and creative/analytical techniques typically acquired in a recognized four-year or more academic course of specialized study. Applies engineering and scientific principles to the evaluation and solution of technical problems in a creative manner unique to each study. Exercises level appropriate technical judgment in planning, organizing, performing, and/or coordinating engineering work.

MAIN RESPONSIBILITIES

  • As a Development Engineer, may perform the following duties for an assigned area: Working from requirement specifications, develops, maintains, and updates detailed design and interface specifications; Participates in and supports the implementation, development, enhancements, and modifications to software source code, scripts, and procedures; Debugs, troubleshoots, and isolates software problems as well as offers strategic solutions, analysis, and advice regarding identified issues for future development; and Identifies parameters, structure, and critical test components. Writes, updates, or executes test design, cases, as well as procedures and reports results.
  • As a Requirements Engineer, may perform the following duties for an assigned area: Writes, updates, and maintains requirement and interface specifications; Contributes to and supports gathering, analyzing, and validating requirements; Contributes to and supports writing, updating, developing and maintaining Hazard/Risk analysis specifications; and Contributes to and supports root-cause analysis of failures.
  • As a Test Engineer, may perform the following duties for an assigned area: Working from requirement specifications, develops, maintains, and updates test requirements and design; Supports implementation, enhancements, and modifications to test cases, procedures, scripts, and code; Debugs, troubleshoots, and isolates software problems and offers strategic advice regarding identified issues for future development; and Identifies parameters, structure, and critical test components. Writes, updates, or executes test design, cases, as well as procedures and reports results.
  • Presents at design reviews; documents and resolves issues as directed.
  • Contributes to and supports reviews held by other engineers on related projects and provide useful feedback.
  • Contributes to and supports a variety of test phase efforts.
  • May write and update requirement specifications for an assigned area.
  • Reviews project deliverables such as specifications, code, and test/tool procedures for feasibility, thoroughness, clarity, correctness, and accuracy.
  • Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
  • Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

QUALIFICATIONS

  • Bachelor’s Degree Engineering discipline, computer science, related engineering field.
  • Experience with visual modeling, graphical user interfaces, multi-threading, networking, relational databases, formal software development methodologies, and source code management is recommended. Experience with unit- and integration-level testing and automated testing is recommended.
  • Experience with Microsoft Office is required. Experience with microprocessor emulators is recommended.
  • Experience with Microsoft Visio is recommended.
  • Experience working in a broader enterprise/cross-division business unit model preferred.
  • Ability to work in a highly matrixed and geographically diverse business environment.
  • Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
  • Ability to leverage and/or engage others to accomplish projects.
  • Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
  • Multitasks, prioritizes and meets deadlines in timely manner.
  • Strong organizational and follow-up skills, as well as attention to detail.


Posted: November 4, 2021, 11:11 am
Category : Manufacturing Engineer
Job Type : Contract
Id : 8529
Region : Twin Cities

The Manufacturing Engineer designs manufacturing processes, procedures and production layouts for assemblies, equipment installation, processing, machining and material handling for a major medical device manufacturer. Designs arrangement of machines within plant facilities to ensure most efficient and productive layout. Designs sequence of operations and specifies procedures for the fabrication of tools and equipment and other functions that affect product performance. Adapts machine or equipment design to factory and production conditions. May incorporate inspection and test requirements into the production plan. Inspects performance of machinery, equipment, and tools to verify their efficiency, and investigates and initiates corrective action of problems and deficiencies to ensure product quality. Develops manufacturing processes that are applicable to statistical process control, and may develop those techniques. Provides guidance to engineering regarding design concepts and specification requirements to best utilize equipment and manufacturing techniques. Ensures processes and procedures are in compliance with regulations.

Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University).

  • Autonomy: Established and productive individual contributor. Works independently with general supervision on larger, moderately complex projects / assignments.
  • Organizational Impact: Sets objectives for own job area to meet the objectives of projects and assignments. Contributes to the completion of project milestones. May have some involvement in cross functional assignments.
  • Innovation and Complexity: Problems and issues faced are general, and may require understanding of broader set of issues or other job areas but typically are not complex. Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area.
  • Communication and Influence: Communicates primarily and frequently with internal contacts. External interactions are less complex or problem solving in nature. Contacts others to share information, status, needs and issues in order to inform, gain input, and support decision making.
  • Leadership and Talent Management: May provide guidance and assistance to entry level professionals and / or employee in Support Career Stream.
  • Required Knowledge and Experience: Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience. Requires a University Degree and minimum of 2 years of relevant experience, or advanced degree with 0 years of experience.


Posted: November 3, 2021, 8:49 am
Category : Technicians
Job Type : Permanent
Id : 8528
Region : Twin Cities

Seeking a Production Technician to support our Semiconductor sensor products. The Production Technician will support engineering with moderately complex engineering duties and/or hands-on tasks. This position will be involved with the overall production and manufacturing of optical sensors or Semiconductor. Coordinate with hardware and software manufacturing engineering teams. Assist in the develop performance models and test procedures.

Key Responsibilities and Essential Functions:

  • Build, align, and calibrate sensor using hand tools, light meters, multimeters, alignment telescopes, autocollimators, theodolites, and lasers.
  • Support Design Engineers with testing and troubleshooting. Analyze test results and adjust equipment to bring it within specifications. Set up and conduct precision optical and mechanical measurements.
  • Coordinate with other departments to install, align, troubleshoot, calibrate, and document changes.
  • Participate in daily production communication meeting to resolve manufacturing issues such as process, fixtures, capacity, and materials to achieve the production build plan.
  • When required, candidate can be assigned to support production capacity to meet revenue plans.
  • Proficient with computer programs like MS Outlook, MS Word, MS PowerPoint, and MS Excel to communicate, calculate, and document.
  • Ability to read mechanical drawings, production build processes, and test procedures.
  • Work closely with APA (Advanced Prototyping Assembler) & Manufacturing Engineering team.
  • Required work hours are from 6:00am to 2:30pm with flexible hours to work outside of standard hours.

Experience, Education, and Competencies Required:

  • Certificate in manufacturing related field and five years of hands-on experience.
  • Ability to understand drawings, specifications, procedures, and geometric tolerances.
  • Self-driven with the ability to multi-task and prioritize within their assigned work scope.
  • Strong troubleshooting skills to decipher between sensor design, fixture, or software issue.
  • Able to articulate problem statement and provide technical strategy to problem solving.
  • Ability to work with minimal supervision, but does not supervise others. Individual will not give work direction. Will provide input to create a solution for process change considerations to be approved by the Manufacturing Engineer or Production Supervisor.
  • Experience, Education, and Competencies Preferred:
  • Two year technical degree in manufacturing related field and two years of hands-on experience.
  • Optical component handling, cleaning, and bonding experience preferred.
  • Experience with optomechanical / electromechanical assembly operations preferred.
  • Working knowledge of small to medium electro/mechanical assembly experience.


Posted: November 3, 2021, 8:29 am
Category : Reliability Engineer
Job Type : Contract
Id : 8526
Region : Twin Cities

The Reliability Engineer develops, coordinates and conducts technical reliability studies and evaluations of engineering design concepts and design of experiments (DOE) constructs. Recommends design or test methods and statistical process control procedures for achieving required levels of product reliability. Completes risk analysis studies of new design and processes. Compiles and analyzes performance reports and process control statistics; investigates and analyzes relevant variables potentially affecting product and processes. Ensures that corrective measures meet acceptable reliability standards. Analyzes preliminary plans and develops reliability engineering programs to achieve company, customer and governmental agency reliability objectives. May develop mathematical models to identify units, batches or processes posing excessive failure risks. As necessary, proposes changes in design or formulation to improve system and/or process reliability. May determine units and/or batches requiring environmental testing, and specifies minimum number of samples to obtain statistically valid data.

Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University).

  • Autonomy: Established and productive individual contributor. Works independently with general supervision on larger, moderately complex projects / assignments.
  • Organizational Impact: Sets objectives for own job area to meet the objectives of projects and assignments. Contributes to the completion of project milestones. May have some involvement in cross functional assignments.
  • Innovation and Complexity: Problems and issues faced are general, and may require understanding of broader set of issues or other job areas but typically are not complex. Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area.
  • Communication and Influence: Communicates primarily and frequently with internal contacts. External interactions are less complex or problem solving in nature. Contacts others to share information, status, needs and issues in order to inform, gain input, and support decision making.
  • Leadership and Talent Management: May provide guidance and assistance to entry level professionals and / or employee in Support Career Stream.
  • Required Knowledge and Experience: Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience. Requires a University Degree and minimum of 2 years of relevant experience, or advanced degree with 0 years of experience.


Posted: November 2, 2021, 6:25 am
Category : Packaging Engineer
Job Type : Contract
Id : 8525
Region : Twin Cities

Seeking a Packaging Engineer

 

Responsibilities may include the following and other duties may be assigned.

  • Design, develop, and tests a wide variety of containers used for the protection, display, and handling of products.
  • Determine packaging specifications according to the nature of the product, cost limitations, legal requirements, and the type of protection required, considering need for resistance to such external variables as moisture, corrosive chemicals, temperature variations, light, heat, rough handling, and tampering.
  • Design package exteriors considering such factors as product identification, sales appeal, aesthetic quality, printing and production techniques.
  • Responsibilities may include documentation management and/or coordination of Good Manufacturing Practices (GMPs), and may support prototype line development in manufacturing facilities/plants.

 

 

Requires a University Degree and minimum of 2 years of relevant experience, or advanced degree with 0 years of experience.



Posted: November 1, 2021, 8:29 am
Category : Software Engineer
Job Type : Contract
Id : 8524
Region : Twin Cities

Seeking a Sr. Software Engineer to be responsible for the following:

 

  • Design, develop, test, debug and implement operating systems components, software tools and utilities.
  • Determine systems software design requirements.
  • Ensure that system improvements are successfully implemented and monitored to increase efficiency.
  • Generate systems software engineering policies, standards and procedures.

 

Requires a University Degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience .



Posted: October 29, 2021, 1:03 pm
Category : Reliability Engineer
Job Type : Contract
Id : 8523
Region : Twin Cities

Seeking a Reliability Engineer

 

  • Responsibilities may include the following and other duties may be assigned. Develop, coordinate and conduct technical reliability studies and evaluations of engineering design concepts and design of experiments (DOE) constructs.
  • Recommend design or test methods and statistical process control procedures for achieving required levels of product reliability.
  • Complete risk analysis studies of new design and processes.
  • Compile and analyze performance reports and process control statistics; investigates and analyzes relevant variables potentially affecting product and processes.
  • Ensure that corrective measures meet acceptable reliability standards.
  • Analyze preliminary plans and develops reliability engineering programs to achieve company, customer and governmental agency reliability objectives.
  • May develop mathematical models to identify units, batches or processes posing excessive failure risks.
  • As necessary, proposes changes in design or formulation to improve system and/or process reliability.
  • May determine units and/or batches requiring environmental testing, and specifies minimum number of samples to obtain statistically valid data.

 

Requires a University Degree and minimum of 2 years of relevant experience, or advanced degree with 0 years of experience.



Posted: October 29, 2021, 8:31 am
Category : Mechanical Engineer
Job Type : Permanent
Id : 8522
Region : Twin Cities

Seeking a Senior Mechanical Automation Engineer who wants to explore the limits of what's possible in life science and medical device technology!

 

Responsibilities:

  • Independently complete all mechanical design tasks throughout project lifecycle
  • Develop new machine concepts and evaluate existing machine concepts
  • Develop detailed mechanical design of automation equipment in SOLIDWORKS
  • Review design with controls engineering team and customer to achieve design approval
  • Create and review mechanical engineering documentation including detail drawings and bill of materials
  • Work with machine assemblers and lead mechanical debug of automation equipment
  • Interface with internal team, vendors, and customers throughout design process
  • Occasionally oversee the work of junior engineers
  • Assist in development of department standards

 

Desired Skills:

  • Strong written and verbal communication skills
  • Strong understanding of custom automation design principles
  • 3D CAD modeling – preferably SOLIDWORKS
  • Knowledge of drafting principles
  • Ability to perform machine design calculations
  • Ability to specify mechanical hardware such as belts, gears, motors, linear actuators, pneumatic components, etc.
  • Ability to create engineering documentation
  • Ability to evaluate design to ensure all safety and ergonomic requirements are met
  • Knowledge of materials and fabrication methods including machining and sheet metal fabrication

 

Requirements:

Bachelor's degree in Mechanical Engineering or equivalent

Minimum of 5 years of experience designing custom automation equipment

Posted: October 27, 2021, 1:47 pm
Category : Technician - Medical Equipment
Job Type : Contract
Id : 8520
Region : Twin Cities

Immediate opportunity for an Automation Build Technician to support equipment build projects for medical device manufacturing.  The Technician will assemble, test, and troubleshoot custom automated equipment and work cells.  This includes electrical control panel wiring, motors, drive systems, mechanical systems, pneumatics, and PLC installations and check-out.

 

Preferred Skills:

  • 2 year degree in Automated Systems Technology or similar
  • Hands on experience with equipment build
  • Must be able to read part drawings, assembly drawings, and electrical and pneumatic schematics
  • Ability to plan equipment build activities
  • Strong mechanical and electrical aptitude
  • Ability to work independently within a custom automation group
  • Knowledge and experience with PLC, HMI, motion control, and pneumatics
  • Medical device development environment experience is a plus


Posted: October 27, 2021, 1:37 pm
Category : Mechanical Engineer
Job Type : Contract
Id : 8518
Region : Twin Cities

Seeking a Sr. Human Factors Design Engineer.

  • Responsibilities may include the following and other duties may be assigned. Apply human performance principles, methodologies, and technologies to the design of humanmachine systems and products.
  • Develop and implement research methodologies and statistical analysis plans to test and evaluate developmental prototypes used in all phases of products development and processes.
  • Design and execute tests to simulate product use for the purposes of concept selection/refinement, requirements development, userelated risk identification and formal usability validation with intended users.
  • Interface with design engineers to establish system design, operating, and training requirements and to ensure optimized humanmachine interfaces.
  • Identify and analyze technological problems or risks, performs theoretical human factors investigations, and develops and implements research and analysis plans.

 

Requires a University Degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.



Posted: October 27, 2021, 6:40 am
Category : Packaging Engineer
Job Type : Contract
Id : 8517
Region : Twin Cities

Seeking a Packing Engineer to design, develop, and test a wide variety of containers used for the protection, display, and handling of products.

  • Determine packaging specifications according to the nature of the product, cost limitations, legal requirements, and the type of protection required, considering need for resistance to such external variables as moisture, corrosive chemicals, temperature variations, light, heat, rough handling, and tampering.
  • Design package exteriors considering such factors as product identification, sales appeal, aesthetic quality, printing and production techniques.

 

Responsibilities may include documentation management and/or coordination of Good Manufacturing Practices (GMPs), and may support prototype line development in manufacturing facilities/plants.

 

Requires a University Degree with 2-5 years of relevant experience.



Posted: October 26, 2021, 9:23 am
Category : Test Engr - Technical
Job Type : Permanent
Id : 8515
Region : Twin Cities

The In-Circuit Test Engineer is responsible for creating test files and performing tester checkout of in-circuit test (ICT) fixture hardware. Assists the production team with the debug and rework of test fixtures which fail ICT.

Major Areas of Accountability:

  • Create basic test files for checkout of test fixtures on one or more ICT platforms.
  • Perform tester checkout on completed ICT fixtures.
  • Support debug and rework of fixtures which do not pass on the ICT platform.
  • Track defect rates for product tested on the ICT platforms.
  • Work proactively with the production team to reduce defects and improve yield.
  • Provide programming for customers looking for turnkey solutions on GenRad 228X and Teradyne ICT platforms, as required.
  • Perform installation, testing, and debug of test fixtures at customer sites, as required.

Education and Experience:

  • Bachelor’s Degree in Electrical Engineering, Computer Science, or equivalent experience in a test engineering environment
  • Experience developing test files for GenRad 228X, Teradyne Z189X, and Teradyne 8800 spectrum series ICT platforms
  • 5 or more years of experience working in an electromechanical manufacturing environment

Knowledge, Skills, and Abilities Required:

  • Strong electronic engineering fundamentals; able to perform root cause failure analysis
  • Excellent verbal and written communication skills
  • Excellent data analysis and presentation skills
  • Great teamwork and interpersonal skills
  • Ability to travel within the US
  • Proven ability to manage working on multiple projects at a time while paying strict attention to detail
  • Proficiency with Microsoft Office Suite
  • Maintains confidentiality and security of intellectual property (ITAR, Prototype)


Posted: October 22, 2021, 12:59 pm
Category : Firmware Engineer
Job Type : Permanent
Id : 8514
Region : Twin Cities

We are seeking a Lead Embedded Linux Software Engineer who has an interest in home automation and a penchant for tech gadgets, IoT and splendid user experiences. You will work closely with our CTO and Product Management team to innovate our customer focused solutions.

What you will be doing:

  • Developing Linux applications for embedded devices and systems
  • Designing our next generation graphic interface
  • Creating software that brings customer and business requirements to life
  • Innovating our award-winning line of products

Required Qualifications:

  • A desire to want to do cool things and have fun while doing it!
  • A BS in Computer Science or a related technical field
  • 5+ years of professional embedded Linux development
  • Demonstrable proficiency in C/C++ software design
  • Experience with GIT or comparable source control software
  • Familiar with MCU and SOC architectures
  • Highly desirable to have a solid understanding and practical experience with Networking communication, Ethernet and wireless TCP/IP and UDP

Preferred Qualifications:

  • Experience using YOCTO or other build systems
  • GUI design experience (Ensemble or similar)
  • Contract engineering experience a plus
  • Experience developing software in the Agile framework
  • RTOS development experience
  • Wireless communications (Wi-Fi, Bluetooth, ZigBee, Z-Wave)
  • Experience with task tracking tools (JIRA)
  • Experience developing IoT / smart home devices


Posted: October 22, 2021, 9:56 am
Category : Technicians
Job Type : Permanent
Id : 8513
Region : Twin Cities

Seeking a Manufacturing Engineer Technician to provide technical support for assembly and RMA functions as well as develop assembly and test procedures. To build, document, and maintain factory production and testing equipment.

Qualifications:

  • At least 2 years of Technical College training in fluid power, robotics, electronics technology or a related field.
  • At least 3 years of related work experience in a manufacturing environment.
  • Strong mechanical and electrical aptitude and problem solving skills.
  • Displays a positive attitude and a strong desire to grow.
  • Ability to communicate and work well with others.
  • Ability to write technical documentation.
  • Demonstrated ability to solve problems in a timely and effective manner.
  • Ability to provide effective equipment documentation.


Posted: October 21, 2021, 8:14 am
Category : Software Engineering
Job Type : Contract
Id : 8512
Region : Twin Cities

Seeking a creative Research Software Engineer or scientist with solid practical software experience, superior communication skills, and a keen desire to learn all aspects Cardiac Mapping System.  Working primarily with software engineers, you will learn to build and deploy the baseline commercial version of the software.  You will then work closely with scientists and engineers in Applied Research and in Human Factors Engineering to help define, prototype, and refine new algorithms and GUI components and incorporate them into new versions of research software.  You will participate in benchtop and preclinical testing to validate your ideas, interact directly with customers to hear and understand their feedback, and help to transfer features into future versions of commercial software.  Your work will result in valuable intellectual property, and you will know that your efforts directly advance the state of the art and help to better diagnose and treat patients with cardiac arrhythmias. 

 

RESPONSIBILITIES:

  • Work with Software Development engineers to understand the overall software architecture and to keep current with the process to create custom research builds of system software.
  • Work with Applied Research scientists and engineers to understand, prototype, and refine a wide variety of signal processing and 3D graphics algorithms, and to incorporate new algorithm ideas into research versions of software.
  • Work with Human Factors engineers to understand, prototype, and refine GUI concepts, and to incorporate them into research versions of software.
  • Test algorithms and GUI concepts through hands-on bench testing and participation in preclinical procedures.
  • Document the design and performance of new features in clearly written reports and participate in reviews with cross-functional teams.  
  • Provide support for invention disclosures and research publications.

 

REQUIRED QUALIFICATIONS:

  • A B.S., M.S. or PhD Degree in any science or engineering discipline.
  • At least 2 years of practical software experience specifically using C++.
  • Good working knowledge of Linux and SW development tools such as Visual Studio, Jira, Perforce.
  • Strong technical communication skills including spoken and written English. 

 

OTHER USEFUL QUALIFICATIONS:

  • GUI development and/or prototyping experience with Qt/QML, Axure, Adobe XD, or similar tools
  • Strong background in mathematics, practical experience with signal processing.
  • Experience with multithreading, OpenGL graphics, Matlab, Python, statistical analysis. 
  • Experience with medical device development, especially related to cardiac electrophysiology. 


Posted: October 21, 2021, 8:09 am
Category : Quality Engineering
Job Type : Contract
Id : 8506
Region : Twin Cities

We're looking for a Quality Engineer I or II with the following experience:

 

Skills:

  • Excellent verbal and written communication skills
  • Interpersonal skills, team player
  • Individual contributor
  • Multi- tasking
  • Strong organizational skills
  • Advanced computer skills

Education/Experience:

  • Bachelor level degree in an Engineering Discipline or other technical field
  • 1 – 5 years of work experience,or internship experience 

Duties:

  • Participate in or lead teams in supporting quality disciplines, decisions, and practices, lead on-time completions of design control deliverables, support on-time execution of Quality Plans for internal product development process (PDP), OEM-based Clinical Product Development (CPDP) and design change projects.
  • Accountable for generation of PDP design verification test plans/reports for product/system requirements, lead or support Risk. Management activities from product concept through commercialization, including generation of risk management plans/reports, completion and maintenance of hazard analysis.
  • FMECA's and Cybersecurity risk assessments, lead identification of essential outputs and generate Essential Output reports.
  • Accountable for completion of labeling verification activities and labeling verification reports, work with design engineering in the completion of customer/system/product requirements.
  • Work with design engineering in the completion of product verification and validation.
  • Endure DHF content completion, integrity and regulatory & standards compliance.
  • Collaborative communication in resolving gaps.
  • Complete document change request reviews in a timely and objective manner.
  • Identify and implement effective process control systems to support the development, qualification and on-going manufacturing of products to meet or exceed internal and external requirements.
  • Assist in the implementation of assurances, process controls and CAPA systems designed to meet or exceed internal and external requirements.
  • Assist in tech development and execution of streamlined business systems which effectively identify and resolve quality issues.
  • Apply sound, systematic problem solving methodologies in identifying, prioritizing, communicating and resolving quality issues.
  • Support all company initiatives as identified by management and in support of quality management systems (QMS), Environmental Management Systems (EMS) and other regulatory requirements.
  • Additional duties may be identified by functional management based on the current project/business objectives.

 

 


 

Posted: October 21, 2021, 4:36 am
Category : Software Engineer
Job Type : Contract
Id : 8505
Region : Twin Cities

Looking for a Software Engineer to join a R&D Organization to support software systems engineering processes and testing of application and embedded software for Medical Device systems. The Software Engineer will also be responsible for supporting the design of processes, tools, documentation, and automated test systems to support this effort.

Areas of responsibilities may include creating design documentation such as architecture, design, and interface specifications for application and embedded software; writing, reviewing, and releasing requirements and test procedures; execution of manual testing and test automation in C#; and supporting a remote/offshore team doing application software testing design and execution. The candidate will drive manual, semi-automated, and automated testing to be implemented depending on automation feasibility, specific functionality coverage, and program needs. Candidates must be able to plan and organize test cases and strategy, generate and review traceability to design requirements, and develop and review test specifications and test reports in compliance with design control procedures used within the medical device industry. Candidates must be willing to work and effectively prioritize multiple responsibilities in a fast-paced team environment.

CAS R&D seeks candidates who will meet our customer expectations by striving without reserve for the greatest possible reliability and quality in our products, processes, and systems by being accountable, having a voice, and taking action.

POSITION RESPONSIBILITIES

  • Support the design documentation and verification testing efforts for Windows-based computing systems software and embedded firmware systems, which are integrated with mechanical and electrical capital equipment.
  • Work in an evolving, maturing Agile environment as part of scrum team, in consultation with scrum masters, product owners, and other developers.
  • Investigate, propose, and implement new technologies, tools, or processes which improve the reliability and efficiency of software testing.
  • Train on and apply the appropriate standards, processes, procedures and tools throughout the software development life cycle, following FDA regulations as well as IEC 62304 for medical device software.
  • Effectively work with individuals from various engineering disciplines in a variety of locations, including supporting Manufacturing in troubleshooting operations through assembly and test.
  • Provide technical assistance to other functional departments such as Quality, Systems Engineering, Reliability, Service, and Manufacturing.
  • Support software deployment and release, supporting and troubleshooting DevOps components, continuous integration, and eventual manufacturing integration/installation and field release.
  • Maintain an attitude of positive flexibility, sometimes performing assigned work outside the boundaries of a typical software engineering job description to meet overall team deadlines and milestones.

BASIC QUALIFICATIONS/EDUCATION/EXPERIENCE

  • 3+ years of software development and/or test experience with bachelor’s degree in Computer Science, Software Engineering, Biomedical Engineering, Electrical Engineering, or other relevant engineering discipline; or 1+ years of experience with advanced degree.
  • 1+ years of experience in a regulated industry, including documentation activities such as technical specifications, requirements traceability, test procedures, and report writing. Able to organize, simplify, and concisely write about complex technical content.
  • 1+ years of experience writing requirements-driven tests in a regulatory environment.
  • Strong verbal and written communication skills.
  • Ability to mentor and review work of less experienced and/or remote engineering teams.
  • Ability to work in a multi-site team environment with strong collaboration skills. Ability to engage with technical and non-technical staff across multiple geographical R&D sites, including significant remote/videoconference-based work.

DESIRED/PREFERRED QUALIFICATIONS

  • 1+ years of experience using .NET/C#.
  • Experience in automated software testing in a Windows environment
  • Experience using Microsoft Visual Studio and Test Manager.
  • Experience developing test software and automation for capital equipment with C# language and .NET framework.
  • Experience with Graphical User Interface (GUI) testing
  • Experience with Team Foundation Server or Azure Devops.
  • Experience with security techniques and protocols.
  • Experience with medical devices or other regulated industries, cardiac ablation or electrophysiology products are a plus.
  • Specific knowledge of FDA software validation requirements and international medical device standards such as 62304.


Posted: October 18, 2021, 9:25 am
Category : Firmware Engineer
Job Type : Contract
Id : 8504
Region : Twin Cities

Looking for a Sr. Firmware Engineer to join a SW/FW Organization to design, develop, and document new designs and modifications to firmware for Medical Devices. The Sr. Firmware Engineer may also be responsible for designing or supporting automated test systems.

Areas of responsibilities may include firmware design, firmware requirements, implementation/coding, technical documentation, test requirements and test procedures, software simulation and test automation. Candidates must be able to translate design inputs into firmware options and concepts, write detailed firmware specifications, implement functionality within the firmware architecture using established design patterns and best practices, generate and review design documentation, interface specifications, test specifications and test reports in compliance with design control procedures used within the medical device industry. Candidates must be willing to work and effectively prioritize multiple responsibilities in a fast-paced team environment.

Cardiac Ablation Solutions seeks candidates who will meet our customer expectations by striving without reserve for the greatest possible reliability and quality in our products, processes and systems by being accountable, having a voice, and taking action.

POSITION RESPONSIBILITIES

  • Work in an evolving, maturing Agile environment as part of scrum team developing medical device firmware, in consultation with scrum masters, product owners, and senior developers.
  • Design, develop, test, document, operate, and maintain firmware components to be applied to and integrated with electromechanical systems.
  • Investigate, propose, and implement new technologies or processes which enhance product features, improve reliability, and/or lower cost.
  • Apply the appropriate standards, processes, procedures, and tools throughout the software development life cycle.
  • Effectively work with individuals from various engineering disciplines in a variety of locations, including supporting manufacturing operations in troubleshooting, assembly, and test.
  • Provide technical assistance to and work effectively with other functional departments such as Systems, Security, Quality, Reliability, and Manufacturing.

BASIC QUALIFICATIONS/EDUCATION/EXPERIENCE

  • 5+ years of firmware development experience with bachelor’s degree in Engineering (Electrical, Software, or Biomedical preferred), or 3+ years of experience with additional advanced degree.
  • Experience with embedded software development in C language.
  • Experience with basic laboratory instruments and tools (e.g. DMM, oscilloscope, protocol analyzer, logic analyzer, spectrum analyzer).
  • Ability to work in a multi-site team environment displaying strong collaboration skills.
  • Self-motivated and be able to work with minimal supervision.
  • Experience in technical specification and report writing.
  • Excellent written and oral communication skills, including the ability to summarize complex technical concepts and problems clearly and concisely.

DESIRED/PREFERRED QUALIFICATIONS

  • M.S. Software or Electrical Engineering
  • Experience in developing firmware using a Real Time Operating System.
  • Experience working with hardware, including ability to read schematics, data sheets and interface specifications.
  • Experience with medical devices or other regulated industries, cardiac ablation or electrophysiology products are a plus.
  • Specific knowledge of FDA software validation requirements and international medical device standards such as 62304.
  • Experience with software security development.
  • Experience with any of: ARM Cortex M processors (preferably STMicro), µC/OS-II real-time operating system, TCP/IP communication and lwIP, microcontroller communication protocols: SPI, I2C, RS232 and USB.
  • Experience with IAR Embedded Workbench and/or Unity unit test framework.


Posted: October 18, 2021, 8:46 am
Category : Quality/Regulatory
Job Type : Contract
Id : 8503
Region : Twin Cities

The Sr. Supplier Quality Engineer ensures that suppliers deliver quality parts, materials, and services. Qualifies suppliers according to company standards and may administer Supplier Owned Quality (SOQ) Program to ensure cost effectiveness. Monitors parts from acquisition through the manufacturing cycle and communicates and resolves supplier related problems as they occur. Evaluates suppliers' internal functions to assess their overall performance and provides feedback in assessment of their operation.

 

Responsibilities:

  • Provide Supplier Quality Engineering support to product development programs for new medical device product
  • Provide input to and align activities to development project schedule
  • Provide technical expertise during supplier evaluation and selection
  • Lead efforts to prepare external CM/OEM supplier's product from development through production release
  • Determine the required supplier process development/validation and qualification activities and partner with Supply Chain to communicate requirements to the suppliers
  • Ensure documentation is completed per quality system procedures for supplier process development/validation and product qualification
  • Establish controls (process, product, inspection) at the supplier through receipt at a high volume manufacturing facility based on risk input
  • Provide status updates as required per assigned projects
  • Apply QSR 21CFR Part 820 (Medical Devices) to everyday applications of Supplier Quality Engineering activities
  • Define, establish and implement supplier quality assurance processes for medical device product
  • Lead or participate in product, business process or quality system level improvement initiatives
  • Provide training and coaching to suppliers or Company personnel on Quality System Regulation, ISO and quality system requirements
  • Participate in internal and supplier audits
  • Travel as required to support assigned projects or other application work requirements. Typically  0 – 25%

 

Required Knowledge and Experience:

Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience. May have practical knowledge of project management. Requires a University Degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.



Posted: October 15, 2021, 7:26 am
Category : Quality Engineer - Medical Device
Job Type : Contract
Id : 8499
Region : Twin Cities

The Quality Engineer develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product. Collaborates with engineering and manufacturing functions to ensure quality standards are in place. Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment. Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications. Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements. May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.

Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University).

  • Autonomy: Established and productive individual contributor. Works independently with general supervision on larger, moderately complex projects / assignments.
  • Organizational Impact: Sets objectives for own job area to meet the objectives of projects and assignments. Contributes to the completion of project milestones. May have some involvement in cross functional assignments.
  • Innovation and Complexity: Problems and issues faced are general, and may require understanding of broader set of issues or other job areas but typically are not complex. Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area.
  • Communication and Influence: Communicates primarily and frequently with internal contacts. External interactions are less complex or problem solving in nature. Contacts others to share information, status, needs and issues in order to inform, gain input, and support decision making.
  • Leadership and Talent Management: May provide guidance and assistance to entry level professionals and / or employee in Support Career Stream.
  • Required Knowledge and Experience: Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience. Requires a University Degree and minimum of 2 years of relevant experience, or advanced degree with 0 years of experience.


Posted: October 12, 2021, 8:47 am
Category : Sr. Applications Engineer
Job Type : Contract
Id : 8488
Region : Twin Cities

Seeking a Data Engineer to be part of a team that designs custom software solutions and builds foundational data analytics and integration platforms for R&D, process development and manufacturing needs.  Use your knowledge and passion for automation, manufacturing and medical devices to help shape the needs the medical device industry.

 

Purpose Statement:

Develops software and foundational platforms used in the development and production of medical devices.  Under limited supervision or as member of a team: directs, develops concepts and executes, designs, plans, and builds data analytics and manufacturing integration platforms.  Also provides support of existing applications in relevant environment(s); troubleshoots problems, execute requirements for upgrades and incremental enhancements.

 

Key Experience:

  • In depth knowledge of SQL Server: Transact SQL, Database design & programming, SSRS reporting, Data Transformation/ETL
  • Experience with database design, stored procedures, functions and/or views, implementation, maintenance (tuning, backup/restore), data migration (on-prem to cloud based SQL technology), SQL Server, PostGres/MySQL, Object/Relational Mapping, and data warehouses.
  • Experience with C#, Python, and/or Go
  • Knowledge of microservices, containerization (Kuberneters/Docker) and AWS
  • Experience with authentication and authorization using Active Directory (on-prem and Azure).
  • Experience with cloud platforms for support and development of solutions, transferring from on prem to cloud architecture models
  • Ensure product robustness through unit tests and other quality control measures

 

Nice to have:

  • Knowledge of working with manufacturing data, MES, PLC
  • Expertise in Full Stack Web Application development


Posted: October 11, 2021, 2:16 pm
Category : Manufacturing Engineer
Job Type : Contract
Id : 8497
Region : Twin Cities

The Senior Manufacturing Engineer designs manufacturing processes, procedures and production layouts for assemblies, equipment installation, processing, machining and material handling. Designs arrangement of machines within plant facilities to ensure most efficient and productive layout. Designs sequence of operations and specifies procedures for the fabrication of tools and equipment and other functions that affect product performance. Adapts machine or equipment design to factory and production conditions. May incorporate inspection and test requirements into the production plan. Inspects performance of machinery, equipment, and tools to verify their efficiency, and investigates and initiates corrective action of problems and deficiencies to ensure product quality. Develops manufacturing processes that are applicable to statistical process control, and may develop those techniques. Provides guidance to engineering regarding design concepts and specification requirements to best utilize equipment and manufacturing techniques. Ensures processes and procedures are in compliance with regulations.

Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University).

  • Autonomy: Seasoned individual contributor. Works independently under limited supervision to determine and develop approach to solutions. Coaches and reviews the work of lower level specialists; may manage projects / processes.
  • Organizational Impact: May be responsible for entire projects or processes within job area. Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments.
  • Innovation and Complexity: Problems and issues faced are difficult, and may require understanding of multiple issues, job areas or specialties. Makes improvements of processes, systems or products to enhance performance of the job area. Analysis provided is in-depth in nature and often provides recommendations on process improvements.
  • Communication and Influence: Communicates with senior internal and external customers and vendors. Exchange information of facts, statuses, ideas and issues to achieve objective, and influence decision making.
  • Leadership and Talent Management: May provide guidance, coaching and training to other employees within job area. May manage projects, requiring delegation of work and review of others' work product.
  • Required Knowledge and Experience: Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience. May have practical knowledge of project management. Requires a University Degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.


Posted: October 11, 2021, 6:57 am
Category : Quality Engineer - Medical Device
Job Type : Contract
Id : 8495
Region : Twin Cities

The Quality Engineer develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product. Collaborates with engineering and manufacturing functions to ensure quality standards are in place. Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment. Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications. Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements. May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.

Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University).

  • Autonomy: Established and productive individual contributor. Works independently with general supervision on larger, moderately complex projects / assignments. Organizational Impact: Sets objectives for own job area to meet the objectives of projects and assignments. Contributes to the completion of project milestones. May have some involvement in cross functional assignments.
  • Innovation and Complexity: Problems and issues faced are general, and may require understanding of broader set of issues or other job areas but typically are not complex. Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area.
  • Communication and Influence: Communicates primarily and frequently with internal contacts. External interactions are less complex or problem solving in nature. Contacts others to share information, status, needs and issues in order to inform, gain input, and support decision-making.
  • Leadership and Talent Management: May provide guidance and assistance to entry level professionals and / or employee in Support Career Stream.
  • Required Knowledge and Experience: Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience. Requires a University Degree and minimum of 2 years of relevant experience, or advanced degree with 0 years of experience.


Posted: October 11, 2021, 6:11 am
Category : Mechanical Engineer
Job Type : Contract
Id : 8493
Region : Twin Cities

The Sr. Mechanical Design Engineer researches, plans, designs, verifies, validates and develops mechanical and/or electromechanical products and systems, such as metals, instruments, controls, plastics, robots, engines, machines and mechanical, resonance, hydraulic or heat transfer systems for production, transmission, measurement, and use of energy. Recommends various technology options or approaches for system, processes, facility or program improvements in terms of safety, performance, efficiency or costs. May be responsible for the transfer from R&D to manufacturing.

Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University).

  • Autonomy: Seasoned individual contributor. Works independently under limited supervision to determine and develop approach to solutions. Coaches and reviews the work of lower level specialists; may manage projects / processes.
  • Organizational Impact: May be responsible for entire projects or processes within job area. Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments.
  • Innovation and Complexity: Problems and issues faced are difficult, and may require understanding of multiple issues, job areas or specialties . Makes improvements of processes, systems or products to enhance performance of the job area. Analysis provided is in depth in nature and often provides recommendations on process improvements.
  • Communication and Influence: Communicates with senior internal and external customers and vendors. Exchange information of facts, statuses, ideas and issues to achieve objective, and influence decision making.
  • Leadership and Talent Management: May provide guidance, coaching and training to other employees within job area. May manage projects, requiring delegation of work and review of others' work product .
  • Required Knowledge and Experience: Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience. May have practical knowledge of project management. Requires a University Degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.


Posted: October 7, 2021, 6:30 am
Category : Electrical Engineer
Job Type : Contract
Id : 8492
Region : Twin Cities

The Sr. Electrical Engineer researches, develops, designs, and tests electrical components, equipment, systems, and networks. Designs electrical equipment, facilities, components, products, and systems for commercial, industrial, and domestic purposes.

Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University).

  • Autonomy: Seasoned individual contributor. Works independently under limited supervision to determine and develop approach to solutions. Coaches and reviews the work of lower level specialists; may manage projects / processes.
  • Organizational Impact: May be responsible for entire projects or processes within job area. Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments.
  • Innovation and Complexity: Problems and issues faced are difficult, and may require understanding of multiple issues, job areas or specialties . Makes improvements of processes, systems or products to enhance performance of the job area. Analysis provided is in depth in nature and often provides recommendations on process improvements.
  • Communication and Influence: Communicates with senior internal and external customers and vendors. Exchange information of facts, statuses, ideas and issues to achieve objective, and influence decision making.
  • Leadership and Talent Management: May provide guidance, coaching and training to other employees within job area. May manage projects, requiring delegation of work and review of others' work product .
  • Required Knowledge and Experience: Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience. May have practical knowledge of project management. Requires a University Degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.


Posted: October 7, 2021, 6:24 am
Category : Quality Engineer - Medical Device
Job Type : Contract
Id : 8490
Region : Twin Cities

Seeking a Sr. Supplier Quality Engineer to work closely with wider supplier quality and operation teams to drive continuous improvement and robust corrective/preventative actions through problem solving techniques at supplier to prevent recurrence of issues, and ultimately deliver high-quality products to customers for a major medical device company.

POSITION RESPONSIBILITIES:

  • Qualifies suppliers according to company standards and may administer a Certified Supplier Program in receiving inspection to ensure cost effectiveness
  • Ensures that suppliers deliver quality parts, materials, and services.
  • Delivering cost-down projects linked directly to Company suppliers
  • Communicate with management and project teams on a regular basis on supplier performance
  • Lead issue resolution of complex problems as they relate to supplied components and materials.
  • Develops and prioritizes an auditing schedule to ensure that designated suppliers are audited on a regular basis to ensure good manufacturing practices (GMP) and quality standards are met
  • Lead and provide technical assistance to suppliers/other resources performing qualification/validation testing. Ensure the resolution of all issues raised during testing/qualification.
  • Work with supplier and sub-tier suppliers, as required, to lead and drive systematic approaches and ensure stability related to medical device quality.
  • Develop strong partnerships with cross functional groups and provide quality leadership within these groups
  • Support in the review of supplier introduction and changes, coordinating activities with suppliers and with internal cross-functional support teams to develop and implement appropriate strategies to qualify and support
  • Ensure appropriate controls are in place at supplier, based on risk associated with product or service
  • Develop and drive technical direction input to component qualification strategies and documentation in conjunction with project teams to ensure high standards are in place
  • Define Receiving Inspection requirements as required and associated test method validation for all internal Company Test Methods.
  • Ensures that suppliers deliver quality parts, materials, and services. Qualifies suppliers according to company standards and may administer a Certified Supplier Program in receiving inspection to ensure cost effectiveness.
  • Monitors parts from acquisition through the manufacturing cycle and communicates and resolves supplier related problems as they occur.
  • Develops and prioritizes an auditing schedule to ensure that designated suppliers are audited on a regular basis to ensure good manufacturing practices (GMP) and quality standards are met.
  • Evaluates suppliers' internal functions to assess their overall performance and provides feedback in assessment of their operation.

POSITION REQUIREMENTS:

  • Qualified to Minimum of a University Bachelors degree in a relevant technical discipline (e.g. Engineering, Science or technical field)
  • Minimum of 4 years relevant experience, or less with an advanced degree
  • A dynamic team player, can work effectively and proactively on cross-functional teams with good communication and technical writing skills
  • Previous experience in Supplier Quality an advantage.


Posted: October 5, 2021, 10:27 am
Category : Systems Engineer
Job Type : Contract
Id : 8486
Region : Twin Cities

The Principal Systems Engineer performs technical planning, system integration, verification and validation, evaluates alternatives including cost and risk, supportability and analyses for total systems. Analyses are performed at all levels of total system product to include: concept, design, fabrication, test, installation, operation, maintenance and disposal. Ensures the logical and systematic conversion of product requirements into total systems solutions that acknowledge technical, schedule, and cost constraints. Performs functional analysis, timeline analysis, detail trade studies, requirements allocation and interface definition studies to translate customer requirements into hardware and software specifications.

Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University).

  • Autonomy: Recognized expert, managing large projects or processes. Exercises considerable latitude in determining deliverables of assignments, with limited oversight from manager. Coaches, reviews and delegates work to lower level specialists.
  • Organizational Impact: Contributes to defining the direction for new products, processes, standards, or operational plans based on business strategy with a significant impact on work group results. May manage large projects or processes that span outside of immediate job area.
  • Innovation and Complexity: Problems and issues faced are difficult, moderately complex and undefined, and require detailed information gathering, analysis and investigation. Develops solutions to moderately complex problems, and/or makes moderate to significant improvements of processes, systems or products independently to enhance performance of job area. Implements solutions to problems.
  • Communication and Influence: Represents organization as a primary contact for specific projects and initiatives; communicates with internal and external customers and vendors at various levels. May negotiate with others to reach understanding or agreement, and influence decision making.
  • Leadership and Talent Management: Typically provides guidance, coaching and training to other employees within job area. Typically manages major / moderately complex projects, involving delegation of work and review of work products, at times acting as a team leader.
  • Required Knowledge and Experience: Requires mastery of a specialty area and full knowledge of industry practices, typically obtained through advanced education combined with experience. May have broad knowledge of project management. Requires a University Degree and minimum 7 years of relevant experience, or advanced degree with a minimum of 5 years of relevant experience.


Posted: October 1, 2021, 7:13 am
Category : Test Engr - Technical
Job Type : Contract
Id : 8485
Region : Twin Cities

We are seeking an experienced Sr. Test Engineer to support our manufacturing process development group. This role is focused on the design and development of software and hardware to test new products.

  • Develops Automatic Test Equipment (ATE) used in manufacturing to verify that Company products are fully functional and free of manufacturing-related defects.
  • Assists others in the design and development of interface hardware, fixtures and circuit boards to test medical capital equipment.
  • Updates existing test software to support updates in product designs. Updates all test system documentation to support changes.
  • Uses engineering background to identify and resolve discrepancies between new design test requirements and test system capabilities.
  • Coordinates deployment of test software and hardware to manufacturing and provides follow-up support to facilitate resolution of problems.
  • Investigates and resolves production problems involving manufacturing test equipment software and hardware
  • Complies with all U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
  • Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
  • Performs other related duties as assigned.

Your experience(s), education and knowledge includes:

  • Bachelor of Science in electrical engineering or related engineering field.
  • Minimum of eight years’ experience in electrical test and test equipment design/development.
  • Minimum of five years of experience programming in National Instruments’ LabVIEW (CLAD and CLD certifications are desirable).
  • Experience with developing test sequences using National Instruments’ TestStand is desirable.
  • Familiarity with Python programming language.
  • Broad familiarity or experience with Automatic Test Equipment (ATE) systems.
  • Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
  • Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
  • Multitasks, prioritizes and meets deadlines in timely manner.
  • Strong organizational and follow-up skills, as well as attention to detail.


Posted: September 30, 2021, 9:46 am
Category : Quality Engineer - Medical Device
Job Type : Contract
Id : 8484
Region : Twin Cities

Seeking a Supplier Quality Engineering to be responsible for the quality of materials and services provided by external suppliers. You will contribute as a team member the EU MDR Remediation key strategic initiative.

Responsibilities may include the following and other duties may be assigned.

  • Drive completion of Technical Documentation remediation related activities.
  • Partner cross-functionally to determine quality impact of supplied components/services.
  • Collaborate with the EU MDR team to ensure deliverables are completed on-time.
  • Provide guidance on direction of EU MDR Supplier Quality deliverables and best way to achieve those deliverables.
  • Assist in developing Supplier Quality Agreements with key suppliers including coordinating negotiations and processing through cross functional approval (Including Legal, Quality and Sourcing Support projects/programs associated with component(s) qualification (Independent reviewer and approver)
  • Review Drawings configuration, mechanical interfaces/operation and material selection to determine the appropriate inspection requirements, methods and sample sizes
  • Review/Approve test plans and reports (qualification, validation) for assigned change and new tool development activities.
  • Develop a strong relationship with supplier as related to quality system issues
  • Develop and maintain strong working relationship with functional groups (R&D, ME, Quality Operations, Supply Chain and Regulatory)
  • Assure the resolution of all issues raised during processing and inspection/testing with supplier.
  • Provide support to sustaining engineering.
  • Provide input into the design, reliability, and manufacturability of new products and coordinate activities within our supplier base. Work closely with component engineers to ensure supplier practices are used across the business.
  • Provide statistical support by the creation of supplier related metrics for the purposes of tracking processing performance and identifying opportunities for supplier improvements.
  • Work with the Quality Management System and maintain compliance with corporate policies, FDA’s QSRs, ISO 9001, IVDD, AIMDD, CMDCAS, CMDR, ISO 13485, MDD/EN46001 and other quality requirements, regulations and guidelines.
  • Use and understand of Statistical Tools (Design of Experiments, Measurement System Analysis, Process Capability and Statistical Process Control)
  • Have expert level knowledgeable of the processes characterization studies and creation of qualification protocols and reports (including structured DOE evaluation and/or IQ/OQ/PQ/PV documentation)
  • Understand Geometric Dimensional Tolerancing (GDT) and apply for inspection setup and tolerancing allowances of molded components

Must Have: Minimum Requirements

  • Bachelor’s degree in Engineering or Science field
  • 0+ years of experience in an engineering role or in the medical device industry

Nice to Haves:

  • Experience working in Medical Device or other highly regulated industry preferred
  • Oral, Presentation and Written communication skills
  • Work in a team/partnership environment
  • Computer Skills (Microsoft- Word, Excel, Project, PowerPoint)
  • Solid understanding of technical principles i.e., risk management, supplier audits, corrective/preventive action, control plans and test method validation
  • Knowledge of applicable GMP, FDA and ISO regulations
  • Practical working knowledge of statistical data analysis and quality improvement tools and techniques


Posted: September 30, 2021, 8:33 am
Category : Software Engineering
Job Type : Contract
Id : 8482
Region : Twin Cities

Seeking a Validation Engineer to ensure the quality of software applications and equipment by validating/qualifying to specifications. This position will provide comprehensive documentation (specifications and validation/qualifications) per the division's policy to meet FDA regulations.

Position Responsibilities Include:

  • Define the development of comprehensive specifications (hardware and/or software) for equipment/software from basic functionality to complex systems such as PLC's, Visual Basic applications, databases, SCADA applications, and systems with FDA defined electronic records and electronic signatures.
  • Provide project estimates independently. Review estimates for Engineer I's.
  • Submit specification, protocol and report for approvals and documentation control via a Change Request.
  • Develop comprehensive software validations and/or equipment qualification protocols per the specification.
  • Execute software validation and/or qualification protocols & record results.
  • Document communicate and follow-up on software/equipment issues.
  • Complete project deliverables per project schedule and monitor project schedule and scope changes to assure team can meet delivery requirements.
  • Create documents, links and Change Requests utilizing a Product Data Management system.
  • Provide information on FDA/QSR regulations and internal process validation policy with regards to software validations, equipment installation qualifications, electronic records & signatures.
  • Develop and review comprehensive validation procedures in compliance with FDA.
  • Perform project lead activities on small to large-scale validation/qualification projects. Participate in vendor evaluations.
  • Provide guidance, mentoring and training to Engineer I's & II's. Ensure consistency of work among Engineer I's & II's. Provide peer reviews on specifications, protocols and reports.
  • Influences and defines functional, departmental and divisional policies & procedures through involvement with cross-functional engineering initiatives.
  • Provide leadership role on championing functional best practices.

Minimum Qualifications:

  • Bachelor’s Degree in Engineering Discipline
  • 5-9 years direct experience
  • Experience in Medical Device manufacturing specifically writing compliance documentation
  • In depth knowledge of MS Office tools
  • Must have excellent organization, clear verbal and written skills
  • Experience working in a SDLC-system development lifecycle
  • Hand on skills using navigating equipment user interfaces
  • High level attention to detail and ability to support multiple priorities at once
  • Must be team-oriented with people skills and positive can-do attitude in dealing with many customers, from various departments (Engineering, R&D, Manufacturing, Regulatory, etc.)

Preferred Qualifications:

  • Experience working in FDA-regulated industry
  • Experience working with a regulatory body in an audit
  • Performed in a quality role ensuring industry compliance
  • Practical knowledge of 21 CFR Part 11 (electronic records/electronic signature)


Posted: September 28, 2021, 8:31 am
Category : Manufacturing Engineer
Job Type : Contract
Id : 8478
Region : Twin Cities

Seeking a Process Development Engineer who applies engineering principles and ingenuity to design and develop manufacturing processes, technologies, tooling, and fixturing for next generation medical devices.

  • Design Support - Establish processes based on product and print requirements. Evaluate process and design alternatives based on Design for Manufacturability principles.
  • Process Optimization - Design and qualify equipment, fixtures, and tooling in order to understand process input and output relations via technical reports and Test Method Validations (TMV).
  • Process Validation - Protocol and report writing, as well as execution of IQ/OQ/PQs, and PPQs.
  • Root Cause Analysis and Troubleshooting - Resolves and/or facilitates the resolution of problems including identifying causes and implementing solutions to prevent re-occurrence.
  • Risk Management - Perform risk management activities using Failure Mode and Effect Analysis methodology (e.g. dFMEA, pFMEA).
  • Production support - Provide technical support for manufacturing processes and equipment to ensure high quality and yield.
  • Lead and interact with functional groups (e.g. research and development, quality, manufacturing, supply chain) as necessary to define work breakdown to achieve project goals related to schedule, performance, and cost.
  • Plan and conduct small to medium size projects. Coordinates and monitors activities. Makes judgments regarding quality of implementation within discipline.
  • Manage program compliance with internal and external standards (e.g. Design Control, Process Validation, and Process Control Plans).
  • Understand work environment issues (e.g. OSHA regulations, etc.).

EDUCATION AND EXPERIENCE

Required

  • Bachelor of Science in Engineering
  • 3-5 years engineering experience
  • prior medical device experience preferred.

Preferred

  • Experience developing manufacturing processes, technologies, and Design for Manufacturability (DFM).
  • Experience with statistical analysis (e.g. Gage R&R, Cpk, SPC, DOE), Six Sigma certification and Minitab experience preferred.


Posted: September 24, 2021, 12:43 pm
Category : Quality/Regulatory
Job Type : Contract
Id : 8477
Region : Twin Cities

The Supplier Quality Engineer ensures that suppliers deliver quality parts, materials, and services. Qualifies suppliers according to company standards and may administer a Certified Supplier Program in receiving inspection to ensure cost effectiveness. Monitors parts from acquisition through the manufacturing cycle and communicates and resolves supplier related problems as they occur. Develops and prioritizes an auditing schedule to ensure that designated suppliers are audited on a regular basis to ensure good manufacturing practices (GMP) and quality standards are met. Evaluates suppliers' internal functions to assess their overall performance and provides feedback in assessment of their operation.

Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University).

  • Autonomy: Established and productive individual contributor. Works independently with general supervision on larger, moderately complex projects / assignments.
  • Organizational Impact: Sets objectives for own job area to meet the objectives of projects and assignments. Contributes to the completion of project milestones. May have some involvement in cross functional assignments.
  • Innovation and Complexity: Problems and issues faced are general, and may require understanding of broader set of issues or other job areas but typically are not complex. Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area.
  • Communication and Influence: Communicates primarily and frequently with internal contacts. External interactions are less complex or problem solving in nature. Contacts others to share information, status, needs and issues in order to inform, gain input, and support decision making.
  • Leadership and Talent Management: May provide guidance and assistance to entry level professionals and / or employee in Support Career Stream. Required Knowledge and Experience:
  • Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience. Requires a University Degree and minimum of 2 years of relevant experience, or advanced degree with 0 years of experience.


Posted: September 24, 2021, 12:32 pm
Category : Test Engr - Technical
Job Type : Contract
Id : 8470
Region : Twin Cities

This Test Engineer position is responsible for providing key technical expertise and organizational leadership and focus for developing the test capability necessary to evaluate products to meet standards compliance, regulatory approval, and business’s needs. This position provides support that spans the full range of research, technology, and development of new and derivative products.

The Test Engineer must be able to work with designers and reliability engineers and technicians to develop and execute strategies that provide the test capabilities necessary to drive decisions and support regulatory submission.

General Responsibilities:

  • Work to effectively plan and provide test capabilities early in project development and drive the identification and proper collection of test objectives, requirements, measures, and metrics.
  • Understand applicable product/system test requirements and provide inputs.
  • Develop, validate, implement test methods and systems to meet design and reliability requirement by collaborating with Design, Reliability, Operations, Regulatory Affairs, and other cross-functional partners. Must be established and productive individual contributor. Works independently with general supervision on larger, moderately complex projects / assignments
  • Lead and execute Installation Qualifications (IQ)
  • Perform re-validation on legacy methods and system
  • Contribute to the completion of group objectives, through building relationships and consensus to reach agreements on assignments.
  • Problem solver. Problem and issues faced in this position are general, and may require understanding of broader set of issues or other job areas but typically are not complex.
  • Makes improvements to processes, systems to enhance better performance.
  • Provide guidance, coaching and training to other lower engineers and Technicians
  • Manages projects, delegation of work and review of reports from others.
  • Lead and participate both mechanical and electrical test development.
  • Communicate clearly the project plans and deliverables to management and project teams where applicable.
  • Supports ISO-17025 lab accreditation.

Minimum Requirements:

  • 4-year advanced engineering degree required. Strong electrical background is preferred
  • Proficient with Microsoft Office applications (Excel and Word)
  • Minimum of 2 years of applicable experience.
  • Knowledge of Verification and Validation (V&V) practices and techniques.
  • PROBLEM SOLVING skills, including demonstrated application of structured problem solving methods and tools
  • Familiar with statistical analysis tools such as Minitab or JMP
  • Experience with testing in both a manual and automated environment
  • Familiar with ISO-17025 lab accreditation


Posted: September 21, 2021, 11:46 am
Category : Software Test Engineer
Job Type : Contract
Id : 8466
Region : Twin Cities

We are seeking high caliber Software Verification Engineer to join our Software Verification team. This Engineer will bring testing expertise to the innovative, and fast-paced verification team. This high caliber, motivated and passionate individual will be responsible for requirements analysis, test design, test execution, defect issue resolution.

Responsibilities include:

  • Work independently and as a team member to plan, write, and execute test cases according to Company practices, FDA regulatory, and ISO standard procedures.
  • Design new test suites for new features and functionality.
  • Perform dry runs and formal Verification activities as required.
  • Setup and configure Test Equipment.
  • Record and close defects found during V&V activities.
  • Perform requirements, design and tests reviews.

Experience and Education Required:

  • Bachelors degree in Computer Science, Computer, Electrical or Biomedical Engineering.
  • Knowledge of software testing. Knowledge of software development lifecycle management tools.
  • Organized, on-time, quick learner and detailed oriented.
  • Excellent documentation skills in delivering information that adds value to managements decision-making process.
  • Experienced in quantitative, analytical, organizational, and follow-up skills.
  • Polished communicator - written documentation and oral presentations/ discussions/ meetings.
  • Excellent reputation for building relationships across various levels of an organization.
  • Energized attitude, proactive thinker and self-starter.


Posted: September 17, 2021, 8:02 am
Category : PC Board Designer
Job Type : Permanent
Id : 8461
Region : Twin Cities

Seeking a PCB Designer that will be integrally involved in all aspects of printed circuit board design including library maintenance, PCB layout of up to ten layers, design verification, and post-processing to prepare for manufacturing.

What You Will Be Doing:

  • Create schematic symbols, component geometries and electronic components utilizing Mentor Graphics Xpedition and PCB Library Expert software.NOTE: If you're an experienced PCB Designer but don't use Xpedition, please check the "Preferred" list at the bottom of this posting to learn what other software packages are acceptable; with your strong knowledge in one of those software packages, we're willing to train you into Xpedition.
  • Alter drawings to meet engineering requirements, and initiate Engineering Change Orders
  • Receive instruction or guidance from Senior PCB designers, Electrical Engineers and Mechanical Engineers, or the Electrical CAD Manager, and collaborate with them to make changes in design and documentation
  • Design and redesign PCBs from schematics and design requirements within the Mentor Graphics Xpedition, Designer and Design Capture software
  • Create drawings, Gerber files and other documentation for PCB fabrication, assembly and internal verification

Required:

  • Associates degree or equivalent in electronics field or similar
  • 5 to 10 years of solid PCB design experience
  • Background in PCB design for Class 2 and Class 3 rigid, rigid flex, and flexible circuit designs utilizing double sided, multilayer and HDI technologies
  • Familiar with IPC specifications and terminology as it relates to PCB manufacturing

Preferred:

  • Preferred is Mentor Graphics Xpedition schematic and PCB design software Release VX.2.0 and later, or PADS Professional VX.2 or later; also acceptable are Cadence, Altium, OrCAD or PADS Designer
  • Familiarity with Fablink and Variant manager processes for creating manufacturing documentation
  • Experience with a PLM system such as Windchill or Teamcenter


Posted: September 15, 2021, 10:11 am
Category : BioMedical Engineer
Job Type : Contract
Id : 8459
Region : Twin Cities

Seeking a Principal Biomedical Engineer to develop biocompatibility strategies and prepare biological evaluation plan for a major medical device company.

Positon Responsibilities:

  • Coordinates and facilitates biocompatibility testing of materials and designs in accordance with FDA requirements, internal SOPs and standards.
  • Liaise with internal resources (design, regulatory, quality, clinical and manufacturing) and external resources, developing and coordinating test strategies with Contract Research Organizations (CROs) to ensure appropriate planning and execution of required testing.
  • Perform gap assessments of products by reviewing legacy documentation and evaluating device BOMs to determine the applicability of test data to ISO 10993 standard.
  • Write biological risk assessments to ensure all the relevant end points mentioned in ISO 10993 are met.
  • Develop and deliver regulatory submission responses to biocompatibility related questions.
  • Participate in the analysis of technical issues and the development of recommendations for project decisions and actions.

Required Knowledge and Experience:

  • Requires mastery of a specialty area and full knowledge of industry practices, typically obtained through advanced education combined with experience.
  • May have broad knowledge of project management.
  • Requires a University Degree and minimum 7 years of relevant experience, or advanced degree with a minimum of 5 years of relevant experience.


Posted: September 14, 2021, 8:45 am
Category : Software Engineer
Job Type : Contract
Id : 8457
Region : Twin Cities

Looking for a Principal Software Test Engineer to join an R&D Organization to lead and develop formal tests for application software for cardiac ablation systems. The Principal Software Test Engineer will also be responsible for designing processes and automated test systems to support this effort.

Areas of responsibilities will include execution of application software test system design, test requirements, test procedures, manual testing, and test automation in C#. The candidate will propose a mix of manual, semi-automated, and automated testing to be implemented depending on automation feasibility, specific functionality coverage, and program needs. Candidates must be able to plan and organize test cases and strategy, generate and review traceability to design requirements, lead and remove roadblocks for an extended, remote team, and develop and review test specifications, code, and test reports in compliance with design control procedures used within the medical device industry. Candidates must be willing to work in a fast paced, multi-tasking, team environment.

POSITION RESPONSIBILITIES

  • Lead the verification testing effort for Windows-based computing systems software, which is integrated with mechanical and electrical systems.
  • Work in an evolving, maturing Agile environment as part of scrum team, in consultation with scrum masters, product owners, and developers.
  • Investigate, propose, and implement new technologies or processes which improve the reliability and efficiency of software testing.
  • Apply the appropriate standards, processes, procedures and tools throughout the system development life cycle.
  • Effectively work with individuals from various engineering disciplines in a variety of locations, including supporting Manufacturing in troubleshooting operations through assembly and test.
  • Provide technical assistance to other functional departments such as Quality, Reliability, and Manufacturing.

BASIC QUALIFICATIONS/EDUCATION/EXPERIENCE

  • 7+ years of application/software systems testing and/or development experience with Bachelor’s Degree in Engineering (Computer Science, Software, Biomedical, or Electrical preferred), or 5+ years of experience with additional advanced degree.
  • 2+ years of direct automated application testing experience with C# language and .NET framework.
  • Strong experience in technical specification, traceability analysis, test case development, and report writing.
  • Ability to mentor, lead, and/or review the work of less experienced and/or remote engineering teams
  • Ability to work with minimal supervision.
  • Ability to work in a multi-site team environment displaying strong collaboration skills.
  • Excellent written and oral communication skills, including the ability to clearly and concisely summarize complex technical concepts and problems.

DESIRED/PREFERRED QUALIFICATIONS

  • Experience using Microsoft Visual Studio and Test Manager.
  • Experience with security techniques and protocols.
  • Experience with medical devices or other regular industries, cardiac ablation or electrophysiology products are a plus
  • Specific knowledge of FDA software validation requirements and international medical device standards such as 62304.


Posted: September 10, 2021, 8:19 am
Category : Quality Engineer - Medical Device
Job Type : Contract
Id : 8456
Region : Twin Cities

The Quality Engineer – Medical Device develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product. Collaborates with engineering and manufacturing functions to ensure quality standards are in place. Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment. Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications. Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements. May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.

Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University).

  • Autonomy: Established and productive individual contributor. Works independently with general supervision on larger, moderately complex projects / assignments.
  • Organizational Impact: Sets objectives for own job area to meet the objectives of projects and assignments. Contributes to the completion of project milestones. May have some involvement in cross functional assignments.
  • Innovation and Complexity: Problems and issues faced are general, and may require understanding of broader set of issues or other job areas but typically are not complex. Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area.
  • Communication and Influence: Communicates primarily and frequently with internal contacts. External interactions are less complex or problem solving in nature. Contacts others to share information, status, needs and issues in order to inform, gain input, and support decision making.
  • Leadership and Talent Management: May provide guidance and assistance to entry level professionals and / or employee in Support Career Stream.
  • Required Knowledge and Experience: Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience. Requires a University Degree and minimum of 2 years of relevant experience, or advanced degree with 0 years of experience.


Posted: September 9, 2021, 8:14 am
Category : Project Manager
Job Type : Contract
Id : 8455
Region : Twin Cities

The Equipment Engineering (EE) Project Manager supports product development programs and Operations projects. In addition, EE Project Management leads teams and coordinates deliverables across EE functions to provide quality solutions on time and within budget. The EE Project Manager has operations and/or process development expertise, and the potential ability to lead a team of representatives from multiple Operations/Process development functions.

Your Responsibilities Include:

  • Must have demonstrated strong leadership capabilities across multiple functions, an excellent ability to communicate at many levels and an ability to quickly and effectively form strong cross-functional working relationships.
  • Works cross functionally to influence, coordinate and drive activities related to Equipment Engineering deliverables.
  • Participates on cross functional project teams to develop clear specifications, influence project direction, evaluates feasibility of concepts through prototyping and risk assessment activities.
  • Applies project management skills to coordinate deliverables, develop and manage timelines, and develop estimates and manage budgets.
  • Establishes milestones and monitors adherence to master plans and schedules, identifies project problems and obtains solutions such as allocation of resources or impact of changing project requirements.
  • Leads and directs Equipment development team(s) on Equipment/Software needs of New Product Development/Technology Development/Operations programs.
  • Identifies, anticipates and manages risks critical to project success. Facilitates cross functional risk mitigation activities.
  • Provides timely and appropriate communication to site leadership and stakeholders.
  • Partner with external vendors to deliver equipment and develop technology that fulfills project requirements.

Basic Qualifications:

  • Bachelor’s degree with 5 plus years of experience, or master’s degree with 3 plus year of experience
  • Excellent verbal and written communication skills
  • Self-starter that can work with minimal supervision
  • Project lead experience working with small and large cross functional teams
  • Demonstrated excellence in data analysis, project planning, and execution

Preferred Qualifications:

  • PMP certification
  • Demonstrated ability to lead and work together with a cross-functional, multi-site team.
  • Strong organization, execution and communication skills.
  • Candidate to have strong leadership and interpersonal skills and ability to build relationships within project teams and customer.
  • Problem solving technical expertise


Posted: September 7, 2021, 12:05 pm
Category : Controls Engineer
Job Type : Contract
Id : 8454
Region : Twin Cities

Seeking a Software Controls Engineer that develops manufacturing/test equipment and software used in the development and production of medical devices. Under limited supervisions or as member of a team: directs, develops, concepts and executes specifications, designs, plans and builds of moderately complex manufacturing and test equipment.

Key Responsibilities:

  • Participates on project teams to develop clear specifications, evaluate feasibility of concepts, and provide estimates for electrical/software designs.
  • Creates electrical/software designs utilizing the departments’ standard development tools and procedures.
  • Procures standard electrical/software components.
  • Coordinates, manages, and documents project designs, estimates, and costs.
  • Prepares standard reports/documentation to communicate status and results.
  • Leads project teams that include Designers, Engineers, and Technicians in the design, assembly, and debug of equipment.
  • Completes FDA/QSR equipment requirements by assisting in the creation of specifications and qualifications.
  • Assists in defining basic mechanical components and automated control requirements.
  • Provides training as required to ensure that the controls systems can be operated effectively.
  • Complete project deliverables and monitor project schedule and scope changes to assure team can meet delivery requirements.

Critical Qualifications:

  • User of the following languages: VB.Net and C#
  • Experience with (user) Aerotech hardware and software


Posted: September 7, 2021, 11:34 am
Category : Technical Writer
Job Type : Contract
Id : 8447
Region : Twin Cities

The Engineering Technical Writer creates, develops, plans, writes and edits operational, instructional, maintenance or test procedures for paper, multimedia, web based publications and user sites; may produce content for embedded user assistance technology. Conducts interviews with various users and technical staff to gather data for documentation. Researches and translates technical information into manuals and/or web based documents for nontechnical and technical users. May document engineering processes and specifications. Recommends formats responsive to technical and customer requirements. Produces products that conform to the company documentation and quality assurance standards.

Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University).

  • Autonomy: Established and productive individual contributor. Works independently with general supervision on larger, moderately complex projects / assignments.
  • Organizational Impact: Sets objectives for own job area to meet the objectives of projects and assignments. Contributes to the completion of project milestones. May have some involvement in cross functional assignments.
  • Innovation and Complexity: Problems and issues faced are general, and may require understanding of broader set of issues or other job areas but typically are not complex. Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area.
  • Communication and Influence: Communicates primarily and frequently with internal contacts. External interactions are less complex or problem solving in nature. Contacts others to share information, status, needs and issues in order to inform, gain input, and support decision making.
  • Leadership and Talent Management: May provide guidance and assistance to entry level professionals and / or employee in Support Career Stream.
  • Required Knowledge and Experience: Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience. Requires a University Degree and minimum of 2 years of relevant experience, or advanced degree with 0 years of experience.


Posted: August 31, 2021, 8:45 am
Category : Manufacturing Engineer
Job Type : Contract
Id : 8446
Region : Twin Cities

Seeking a Sr. Manufacturing Engineer to be responsible for the following and other duties may be assigned.Designs manufacturing processes, procedures and production layouts for assemblies, equipment installation, processing, machining and material handling.Designs arrangement of machines within plant facilities to ensure most efficient and productive layout. Designs sequence of operations and specifies procedures for the fabrication of tools and equipment and other functions that affect product performance.Adapts machine or equipment design to factory and production conditions. May incorporate inspection and test requirements into the production plan. Inspects performance of machinery, equipment, and tools to verify their efficiency, and investigates and initiates corrective action of problems and deficiencies to ensure product quality.Develops manufacturing processes that are applicable to statistical process control, and may develop those techniques.Provides guidance to engineering regarding design concepts and specification requirements to best utilize equipment and manufacturing techniques. Ensures processes and procedures are in compliance with regulations.Nice to have:Practice with to high- and low-power laser system operation/testing/troubleshooting. Laser Optical collimation techniques, Experience with optical measuring equipment, Working knowledge of properties of light specifically lasers.Requires a University Degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.

Posted: August 30, 2021, 12:56 pm
Category : Materials Engineer
Job Type : Contract
Id : 8444
Region : Twin Cities

The Materials Engineer analyzes, researches, designs and develops materials and their related fabrication and application processes to develop and optimize materials for use in engineering design of and/or application in structures, systems and subsystems. Applies principles of chemistry, physics, and material behavior to develop metallic, nonmetallic and composite material and processing specifications, fabrication and assembly processes. Develops, analyzes and applies material properties and design allowables, processing processes and quality engineering specifications. Material analyses may include failure analysis of components, systems and subsystems, life predictions, and definition and requirement specifications. May review and approve subcontractor material processing procedures.

Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University).

  • Autonomy: Seasoned individual contributor. Works independently under limited supervision to determine and develop approach to solutions. Coaches and reviews the work of lower level specialists; may manage projects / processes.
  • Organizational Impact: May be responsible for entire projects or processes within job area. Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments.
  • Innovation and Complexity: Problems and issues faced are difficult, and may require understanding of multiple issues, job areas or specialties. Makes improvements of processes, systems or products to enhance performance of the job area. Analysis provided is in depth in nature and often provides recommendations on process improvements.
  • Communication and Influence: Communicates with senior internal and external customers and vendors. Exchange information of facts, statuses, ideas and issues to achieve objective, and influence decision making.
  • Leadership and Talent Management: May provide guidance, coaching and training to other employees within job area. May manage projects, requiring delegation of work and review of others' work product.
  • Required Knowledge and Experience: Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience. May have practical knowledge of project management. Requires a University Degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.


Posted: August 27, 2021, 9:07 am
Category : Systems Engineer
Job Type : Contract
Id : 8440
Region : Twin Cities

The Systems Engineer performs software validation planning and execution through collaboration on system verification and validation strategy. Evaluates alternatives including unit test and black box testing for total system risk management. Ensures the logical and systematic conversion of user requirements, equipment requirements, and infrastructure requirements into a total system solution that acknowledges technical, schedule, and cost constraints. Performs functional analysis, timeline analysis, requirements allocation and interface definition studies to translate customer requirements into hardware and software specifications.

Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills.

  • Autonomy: Established and productive individual contributor. Works independently with general supervision on larger, moderately complex projects / assignments.
  • Organizational Impact: Sets objectives for own job area to meet the objectives of projects and assignments. Contributes to the completion of project milestones . May have some involvement in cross functional assignments.
  • Innovation and Complexity: Problems and issues faced are general, and may require understanding of broader set of issues or other job areas but typically are not complex . Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area. Previous experience performing validation on .NET and PLC applications a plus.
  • Communication and Influence: Communicates primarily and frequently with internal contacts . External interactions are less complex or problem solving in nature. Contacts others to share information, status, needs and issues in order to inform, gain input, and support decision making.
  • Leadership and Talent Management: May provide guidance and assistance to entry level professionals and / or employee in Support Career Stream.
  • Required Knowledge and Experience: Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience. Requires a University Degree and minimum of 2 years of relevant experience, or advanced degree with 0 years of experience.


Posted: August 25, 2021, 6:29 am
Category : Technician - Medical Equipment
Job Type : Contract
Id : 8436
Region : Twin Cities

The Industrial Controls Technician III designs, delivers, and supports equipment solutions for a wide range of innovative medical electronics-based products and process control equipment. They are responsible for the development and release of equipment solutions supporting the release of new product manufacturing lines.

This position would be responsible for designing and implementing both the software and controls hardware solution set. The equipment solution development includes integration of software and hardware and will include debugging while interfacing to the equipment; perform R&R (repeatability & reproducibility) analyses; qualification and validation documentation, and support for system releases. This position will utilize Beckhoff hardware and software environments and/or structured text for development. This position will troubleshoot software and hardware problems using root cause analysis and provides technical solutions for equipment-related problems and provides yield improvement solutions.

POSITION RESPONSIBILITIES:

  • Developing software applications using Automated Equipment to manufacture or test electronic components utilizing Beckhoff hardware and software.
  • Designing, developing, and debugging dedicated Beckhoff hardware and software, performing verification and validation activities, performing Measurement Systems Analysis (Gage R&R studies)
  • Deployment and qualification and of equipment. Ensures appropriate documentation is maintained and completed for all technology programs transferred to product line specific areas
  • Design and qualify new custom tooling/equipment (IQ/OQ/PQ, Support)
  • Troubleshooting yield and performance issues to root cause using statistics-based analyses and providing related technical solutions
  • Following software application development procedures and demonstrate compliance through technical documentation generation
  • Work is performed with minimal direction
  • All activities must be performed in compliance with the Quality System.
  • All other duties as assigned
  • Candidates will be required to work with equipment onsite for commissioning and debugging. This may require 100% onsite work.

POSITION REQUIREMENTS:

  • High School diploma or GED
  • Preferred: Associates degree in Electrical or automation Technology
  • Preferred: Bachelors in Electrical Engineering, Controls Engineering, Industrial Engineering, Computer Engineering or related Engineering discipline
  • 4+ years of experience in Engineering Design and Development
  • 1+ years of hands on experience working with Beckhoff programmable automation controllers


Posted: August 19, 2021, 2:29 pm
Category : Electrical Engineer
Job Type : Contract
Id : 8433
Region : Twin Cities

Seeking a junior to mid-level Electrical Engineer to provide assistance to the Released Product Engineering group (a.k.a. continuation engineering, sustaining engineering, product support) for a major medical device company. This group participates in several cross functional teams for market released external medical instrumentation products. Cross functional project teams include members from Product Development, Manufacturing, Marketing, Sourcing, Contract Manufacturing Engineering, Quality, Reliability, and Regulatory functions. The group’s primary objective is to provide the design expertise necessary to support continuity of quality and compliant products. This electrical engineer will be taking work direction from the engineers on staff to fulfill various technical and documentation responsibilities.

Position Responsibilities:

  • Assess supplier driven changes, component changes, and component obsolescence for potential impact against product functional requirements and document the testing required or rationale (analysis) for no testing.
  • Create test plans and reports, and coordinate product testing.
  • Evaluate returned product to determine the root cause of field returns and establish design improvements.
  • Create and implement CO/CAs in Comany’s Product Data Management system. This includes leading the cross functional change review and approval process.
  • Communicate technical details and achieve the necessary understanding and trust from non-technical audiences.
  • Provide technical expertise to support electrical and mechanical projects that expand the capabilities of existing product and system solutions.
  • Review and analyze circuit schematics and technical component specifications.
  • Design, simulate, and test analog and digital circuits either independently or while working closely with a design technician for the development of improved solutions and evaluation of returned product.
  • Generate high quality formal documentation and records.
  • Manage, configure, track, verify, and transport test samples.
  • Assess the impact of changing regulatory standards on existing medical products and assess the impact of changes in medical products against existing regulatory standards.
  • Typical issues are reactive and are often urgent, so priorities change frequently, and issues must be resolved quickly to assure quality and continuity of supply. Some issues requiring resolution may contain a mechanical element as well. Leverage area expertise and learn new design elements to quickly become the design expert as issues require.

Required Qualifications:

  • 0 to 5 years industry experience
  • Bachelor of Electrical Engineering or another engineering discipline with a very strong focus in electronics
  • Must have the capability of functioning independently as an Electrical Engineer with minimal supervision
  • Skills include analog/digital circuit design and troubleshooting, laboratory practices, circuit simulation, product testing, and design of experiments
  • Demonstrated problem solving skills
  • Strong written communication skills
  • Proven experience working effectively both independently and with multi-functional teams.

Desired Qualifications:

  • Experience in a regulated industry (e.g. medical, aerospace, military).
  • Experience in the development or support of medical products
  • Experience with evolving technology such as USB, Bluetooth, mobile (cellular) technology, and WiFi
  • Experience in manufacturing or post market support
  • General understanding of how to interpret and apply industry recognized standards, especially for medical electronic products
  • Strong verbal skills
  • Experience with quick turn assignments


Posted: August 18, 2021, 12:17 pm
Category : Manager
Job Type : Permanent
Id : 8422
Region : Twin Cities

Seeking an Engineering Manager to direct, manage, and supervise catheter engineers and technicians in the design, development, and testing of disposable medical devices used in interventional cardiac MR (iCMR) procedures. This position is responsible for complying with the Quality System requirements and carrying out responsibilities as outlined in the environmental, health, and safety policies. 

 

Responsibilities

  • Manage team resources to ensure products are developed on-time and conform to the organization's specifications.
  • Collaborate with other engineering disciplines, management, sales and marketing, and related departments as necessary to determine engineering feasibility, cost effectiveness, and demand for engineering products and services.
  • Hire, train and manage employees and their activities to ensure high performance and accountability, collaboration, respect for diversity, and employee job satisfaction.
  • Develop processes, policies, and procedures and ensure all engineering projects align with the organization's objectives.
  • Provide scheduling and budgetary input to overall Engineering department strategy.

 

Qualifications

  • BA/BS in engineering or related field.
  • 5 years minimum engineering experience, preferred in the medical device industry.
  • 2 years minimum management experience.
  • Prior experience managing engineering teams is desired.
  • Catheter development experience a plus, but not required.
  • Demonstrate the ability to identify and manage proficiencies and deficiencies in the department (e.g. skills, resources, etc.).
  • Demonstrate the ability to communicate priorities and decisions clearly and effectively.
  • Experience with Microsoft Office: Word, Excel, PowerPoint.


Posted: August 6, 2021, 6:07 am
Category : Software Engineer
Job Type : Permanent
Id : 8420
Region : Twin Cities

Seeking a Software Engineer to be responsible for the implementation of software for sensors, systems and internal manufacturing processes. A Software Engineer generally works at the direction of a Senior Software Engineer, Software Architect or Systems Engineer.

Core Responsibilities

  • Implement software for sensors, systems, fixtures and internal infrastructure projects.
  • Write unit tests and stress tests for validation of software performance
  • Assist in testing software releases for other members of the team
  • Document software designs and instructions for use
  • Support and maintain software that is released to internal and external customers
  • Participate in software process improvement team
  • Stay up to date on latest software techniques and trends

Experience, Education and Competencies Required

  • BS Degree in Computer Science or Electrical Engineering (or similar)
  • Proficiency in C# programming
  • Working knowledge of Microsoft Visual Studio and source control tools

Experience, Education and Competencies Preferred

  • Experience in C++ programming
  • Experience in Matlab or Python programming
  • Experience with user interface design with Winforms and WPF
  • Experience with communication protocols such as RS-232, TCP/IP and USB 3.0
  • Experience with image acquisition systems and image processing software
  • Experience working with multi-discipline engineering teams


Posted: August 5, 2021, 2:02 pm
Category : Mechanical Engineer
Job Type : Contract
Id : 8418
Region : Twin Cities

Seeking an experienced Mechanical Design Engineer to research, plan, design, verify, validate and develop mechanical and/or electromechanical products and systems for a major medical device company.  The ideal candidate should be able to recommend various technology options or approaches for system, processes, facility or program improvements in terms of safety, performance, efficiency or costs. May be responsible for the transfer from R&D to manufacturing

 

Required Experience:

  • Bachelors degree with previous mechanical design or manufacturing engineering experience
  • Technical writing
  • Rapid Prototyping
  • Experience with medical device instruments or consumer electronics is a plus


Posted: August 4, 2021, 10:02 am
Category : Software Engineering
Job Type : Contract
Id : 8417
Region : Twin Cities

Seeking a Principal Software Engineer to provide services in connection with the design, development, and quality assurance of company’s Primary Battery Life Test features and applications against a jointly prioritized backlog of features and enhancements for a major medical device company. The features include:

  • Commissioning and calibration station (requires strengths in LabVIEW 17 and REST commands)
  • Configuration station (requires strengths in C#, .net, database queries)

Additional Responsibilities:

  • Continually updating and prioritizing business requirements in the form of a JIRA backlog
  • Automated test case development for new and updated features
  • Documentation and knowledge transfer to company resources regarding architecture updates and API changes
  • Delivery management; including in Sprint documentation and reporting

Required Knowledge and Experience:

  • Bachelor of Science with a minimum 7 years of relevant experience, or advanced degree with a minimum of 5 years of relevant experience


Posted: August 4, 2021, 6:25 am
Category : Hardware Engineer
Job Type : Contract
Id : 8416
Region : Twin Cities

Seeking a Sr. Hardware Engineer to work within the Pre-mkt Quality, Cardiac Rhythm Management Business for a major medical device company.

Responsibilities may include the following and other duties may be assigned:

  • Conducts reliability analysis, and testing of electrical or mechanical hardware such as computer chips, circuit boards, mechanical and electrical components.
  • Ensures reliability, analyzes hardware configuration, leads risk analysis (FMEA/FTA), and tests hardware conformance to specifications.
  • Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University).
  • Autonomy: Seasoned individual contributor. Works independently under limited supervision to determine and develop approach to solutions. Coaches and reviews the work of lower level specialists; may manage projects / processes.
  • Organizational Impact: May be responsible for entire projects or processes within job area. Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments.
  • Innovation and Complexity: Problems and issues faced are difficult, and may require understanding of multiple issues, job areas or specialties. Makes improvements of processes, systems or products to enhance performance of the job area. Analysis provided is in depth in nature and often provides recommendations on process improvements.
  • Communication and Influence: Communicates with senior internal and external customers and vendors. Exchange information of facts, statuses, ideas and issues to achieve objective, and influence decision making.
  • Leadership and Talent Management: May provide guidance, coaching and training to other employees within job area. May manage projects, requiring delegation of work and review of others' work product.
  • Required Knowledge and Experience: Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience. May have practical knowledge of project management. Requires a University Degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.


Posted: August 3, 2021, 10:12 am
Category : Project Leader
Job Type : Permanent
Id : 8414
Region : Twin Cities

Seeking a Machining Supervisor to lead, supervise, and coordinate work activities within assigned Machine Shop and/or Tube Shop work centers (areas included are the CNC Lathes which include standard single spindle single turret, twin spindle twin turret and mill turn machines, CNC Horizontals Mills and CNC vertical mills, cylindrical grinding, and Swiss machining, Manual Machining, saw operations, and Anodizing) in a manner which is consistent with Company policies and procedures.

Qualifications:

  • High school education or equivalent, plus at least 2 years of technical training in machine tool technology or a related field.
  • At least 5 years of CNC milling/turning/grinding set-up and operating experience, most of which must be in a short run environment involving a series of complicated operations. At least 2 years of experience in supervisory capacity.
  • Advanced knowledge of blueprint reading, geometric dimensioning and tolerancing, SPC, and mechanical inspection.
  • Knowledge of programming and multi-axis concepts in both manual and CNC environments.
  • Very strong mechanical aptitude and problem solving skills.
  • Ability to set-up, operate, and verify the quality of work on a wide variety of CNC and manual milling/turning work centers.
  • Experience with close tolerances and precise measurements.
  • Must exhibit strong leadership and sound decision making skills.
  • Ability to communicate effectively, both verbally and in writing, with a wide variety of company personnel and others at all levels.
  • Strong project management skills.
  • Understanding of 5S and help implement continuous improvement efforts.


Posted: August 2, 2021, 7:28 am
Category : Packaging Engineer
Job Type : Contract
Id : 8412
Region : Twin Cities

The Sr. Packaging Engineer designs, develops, and tests a wide variety of containers used for the protection, display, and handling of products. Determines packaging specifications according to the nature of the product, cost limitations, legal requirements, and the type of protection required, considering need for resistance to such external variables as moisture, corrosive chemicals, temperature variations, light, heat, rough handling, and tampering. Designs package exteriors considering such factors as product identification, sales appeal, aesthetic quality, printing and production techniques. Responsibilities may include documentation management and/or coordination of Good Manufacturing Practices (GMPs), and may support prototype line development in manufacturing facilities/plants.

Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University).

  • Autonomy: Seasoned individual contributor. Works independently under limited supervision to determine and develop approach to solutions. Coaches and reviews the work of lower level specialists; may manage projects / processes.
  • Organizational Impact: May be responsible for entire projects or processes within job area. Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments.
  • Innovation and Complexity: Problems and issues faced are difficult, and may require understanding of multiple issues, job areas or specialties. Makes improvements of processes, systems or products to enhance performance of the job area. Analysis provided is in-depth in nature and often provides recommendations on process improvements.
  • Communication and Influence: Communicates with senior internal and external customers and vendors. Exchange information of facts, statuses, ideas and issues to achieve objective, and influence decision making.
  • Leadership and Talent Management: May provide guidance, coaching and training to other employees within job area. May manage projects, requiring delegation of work and review of others' work product.
  • Required Knowledge and Experience: Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience. May have practical knowledge of project management. Requires a University Degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.


Posted: July 30, 2021, 11:22 am
Category : Software Engineer
Job Type : Contract
Id : 8411
Region : Twin Cities

The Principal Software Engineer designs, develops, tests, debugs and implements operating systems components, software tools and utilities. Determines systems software design requirements. Ensures that system improvements are successfully implemented and monitored to increase efficiency. Generates systems software engineering policies, standards and procedures.

Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University).

  • Autonomy: Recognized expert, managing large projects or processes. Exercises considerable latitude in determining deliverables of assignments, with limited oversight from manager. Coaches, reviews and delegates work to lower level specialists.
  • Organizational Impact: Contributes to defining the direction for new products, processes, standards, or operational plans based on business strategy with a significant impact on work group results. May manage large projects or processes that span outside of immediate job area.
  • Innovation and Complexity: Problems and issues faced are difficult, moderately complex and undefined, and require detailed information gathering, analysis and investigation. Develops solutions to moderately complex problems, and/or makes moderate to significant improvements of processes, systems or products independently to enhance performance of job area. Implements solutions to problems.
  • Communication and Influence: Represents organization as a primary contact for specific projects and initiatives; communicates with internal and external customers and vendors at various levels. May negotiate with others to reach understanding or agreement, and influence decision-making.
  • Leadership and Talent Management: Typically provides guidance, coaching and training to other employees within job area. Typically manages major / moderately complex projects, involving delegation of work and review of work products, at times acting as a team leader.
  • Required Knowledge and Experience:  University Degree and minimum 7 years of relevant experience, or advanced degree with a minimum of 5 years of relevant experience.

 

Must Have

  • C# (.NET) programming
  • C# Application
  • Unit tests
  • DevOps
  • GIT
  • C++
  • Linux

 

Nice to Have

  • Hardware Emulation


Posted: July 29, 2021, 8:12 am
Category : Reliability Engineer
Job Type : Contract
Id : 8404
Region : Twin Cities

The Software Reliability Engineer develops, coordinates and conducts technical reliability studies and evaluations of engineering design concepts and design of experiments (DOE) constructs. Recommends design or test methods and statistical process control procedures for achieving required levels of product reliability. Completes risk analysis studies of new design and processes. Compiles and analyzes performance reports and process control statistics; investigates and analyzes relevant variables potentially affecting product and processes. Ensures that corrective measures meet acceptable reliability standards. Analyzes preliminary plans and develops reliability engineering programs to achieve company, customer and governmental agency reliability objectives. May develop mathematical models to identify units, batches or processes posing excessive failure risks. As necessary, proposes changes in design or formulation to improve system and/or process reliability. May determine units and/or batches requiring environmental testing, and specifies minimum number of samples to obtain statistically valid data.

Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University).

Autonomy: Established and productive individual contributor. Works independently with general supervision on larger, moderately complex projects / assignments. Organizational Impact: Sets objectives for own job area to meet the objectives of projects and assignments. Contributes to the completion of project milestones. May have some involvement in cross functional assignments.

Innovation and Complexity: Problems and issues faced are general, and may require understanding of broader set of issues or other job areas but typically are not complex. Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area.

Communication and Influence: Communicates primarily and frequently with internal contacts. External interactions are less complex or problem solving in nature. Contacts others to share information, status, needs and issues in order to inform, gain input, and support decision making.

Leadership and Talent Management: May provide guidance and assistance to entry level professionals and / or employee in Support Career Stream.

Required Knowledge and Experience: Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience. Requires a University Degree and minimum of 2 years of relevant experience, or advanced degree with 0 years of experience.



Posted: July 22, 2021, 1:23 pm
Category : Software Test Engineer
Job Type : Permanent
Id : 8392
Region : Twin Cities

Seeking a Sr. Software Test Engineer- LabVIEW to provide end to end development of TestStand/LabVIEW solutions for custom functional test systems including, writing requirements; test system development and integration; acceptance testing and technical support.

 

Major Areas of Accountability:

  • Develop LabVIEW software test system requirements
  • Design LabVIEW software solutions that satisfy test system requirements
  • Lead or participate in design review meetings
  • Collaborate with other engineering disciplines to ensure effective overall system design
  • Provide technical leadership on projects involving multiple engineers, including leading the overall design approach partitioning work among the team and sequencing detailed design activities to support the overall project schedule
  • Support the sales process by providing technical expertise in customer proposals
  • Provides effective communication with project team members, including project status, risks and suggestions to project leadership
  • Collaborate with customers as needed to accomplish customer goals

 

Education and Experience:

  • Bachelor's Degree in Electrical Engineering, Computer Science or equivalent experience in a test engineering environment
  • 5 – 10 years of work experience using TestStand and LabVIEW
  • CLD or CLA is preferred

 

Knowledge, Skills, and Abilities:

  • Ability to design TestStand and LabVIEW architectures based on system requirements
  • Application software development skills in Microsoft Visual Studio (VB.NET/C#). C/C++ experience a plus
  • Analyze existing test solution (electrical/software) and understand the design for maintenance or updating/upgrading test software
  • Solid analytical skills; able to resolve technical problems with innovative solutions
  • Proven ability to manage working on multiple projects at a time while paying strict attention to detail
  • Proficiency with Microsoft Office Suite
  • Effective verbal and written communication skills
  • Capacity to deal with a high workload and deadline pressure
  • Requires a strong initiative, proactive nature and a sense of urgency
  • Ability to travel 0% - 10% to client locations for meetings and/or system installations
  • Ability to work extended hours as necessary to meet deadlines
  • Must be able to perform in a team environment with good interpersonal skills with commitment to the highest quality achievable
  • Maintains confidentiality and security of intellectual property (ITAR, Prototype)


Posted: July 8, 2021, 8:23 am
Category : Mechanical Engineer
Job Type : Permanent
Id : 8375
Region : Twin Cities

Seeking a Mechanical Engineering Manager to be responsible for leading and supervising a team of highly skilled mechanical engineers and designers as they provide technical solutions to address our customers challenging medical device development programs. These programs include complex electromechanical systems from mobile health devices to implantables.

Essential Duties and Responsibilities:

  • Perform lead engineering role as sole engineer or as part of a team.
  • Recruit and maintain staff. Resources projects with employees, independent contractors, and temporary contractors.
  • Mentors/coaches staff. Develops and leads staff to establish and maintain excellence in technical expertise.
  • Sets work direction and oversees engineering work. Assists with overcoming roadblocks.
  • Works hand in hand with staff, Program Managers and customers to ensure optimal and sound engineering solutions are implemented within budget and schedule.
  • Keep abreast of regulations, standards and provide training to staff and others.
  • Responsible for identification, purchase, training, and maintenance of tools and equipment.
  • Support internal groups across the organization.
  • Establishes and maintains processes/procedures. Ensures policies and processes are followed. Effectively creates and supports process enhancement initiatives.

To perform the job successfully, an individual should demonstrate the following competencies:

  • Achievement Focus - Sets and achieves challenging goals; demonstrates persistence and overcomes obstacles; measures self against standard of excellence; recognizes and acts on opportunities; takes calculated risks to accomplish goals.
  • Communications - Expresses ideas and thoughts verbally; expresses ideas and thoughts in written form; exhibits good listening and comprehension; keeps others adequately informed; selects and uses appropriate communication methods.
  • Managing Customer Focus - Promotes customer focus; establishes customer service standards; provides training in customer service delivery; monitors customer satisfaction; develops new approaches to meeting customer needs.
  • Managing People - Includes staff in planning, decision-making, facilitating and process improvement; takes responsibility for subordinates' activities; makes self-available to staff; provides regular performance feedback; develops subordinates' skills and encourages growth; solicits and applies customer feedback (internal and external); fosters quality focus in others; improves processes, products and services; continually works to improve supervisory skills.
  • Planning and Organization - Prioritizes and plans work activities; uses time efficiently; plans for additional resources; sets goals and objectives; organizes or schedules other people and their tasks; develops realistic action plans.
  • Problem Solving - Identifies and resolves problems in a timely manner; gathers and analyzes information skillfully; develops alternative solutions; works well in group problem solving situations; uses reason even when dealing with emotional topics.

Supervisory Responsibilities:

  • Directly supervises employees - Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws.
  • Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.

Education/Experience:

  • Bachelor of Science degree in science related field
  • Minimum of 7+ years of experience with demonstrated success in Medical Product Development Minimum 3 years in a leadership role.
  • Knowledge of medical device Regulations (examples: 21 CFR, ISO 13485, ISO 14971, ISO 9001, etc.).
  • Comprehensive knowledge of mechanical engineering in a regulated field is a must.


Posted: June 25, 2021, 11:25 am
Category : Electrical Engineer
Job Type : Permanent
Id : 8338
Region : Twin Cities

We are looking for a Senior Electrical Engineer who will play an integral role in our R&D team, working the start to finish process of planning through implementation in production of our electronic components for our high precision semiconductor inspection and measurement sensors. This position is responsible for project planning, design, implementation, design verification, transition to production, continuation, and communication of their activities to internal customers.

Core Responsibilities:

  • Interpret customer and internal product requirements and translate into product specifications, risks, and design concepts.
  • Risk reduction through feasibility studies of initial electronics concepts.
  • Contribute to project planning by estimating tasks, resources, schedules, NRE, production costs, and manufacturing support.
  • Design electrical circuits that encompass analog processing of highly accurate sensors, analog to digital conversion, high speed processor design, high speed memories, WIFI, Bluetooth, QI battery charging, CMOS imagers, lasers, photodiodes, FPGA’s, and power management.
  • Supervision of PCB layout activities that must achieve challenging size, space, weight, and high-speed board requirements.
  • Manage fabrication and testing of prototype and production electrical designs.
  • Design verification to internal specifications and standards.
  • Ability to design products to meet CE and other international compliance requirements.
  • Development of manufacturing calibration and alignment processes.
  • Transition of new designs to manufacturing and support of existing product.
  • Strong communications skills with management and other functional areas.
  • Mentoring of Junior Engineers and Technicians

Experience, Education and Competencies Required

  • Experience – 10+ years work experience including
  • Highly experienced in sensing and digitizing fundamental physical properties like; temperature, humidity, pressure, vibrations, inclination, displacement, capacitance, resistance, and others.
  • Embedded processor designs that read sensor data, process that data, and communicate the results via WIFI or Bluetooth. Design skills include processor peripherals like DDR and FLASH memories, high performance ADCs or DACs, and I2C and SPI devices.
  • Knowledge of RF fundamentals relating to WIFI and Bluetooth.
  • FPGA logic and digital signal filtering experience.
  • Wireless Li-Ion battery charging, battery fuel gauges, processor PMICs, and high efficiency power supply design.
  • Strong documentation skills that encompasses schematic capture, PCB and BOM file management, theory of operation and design descriptions, test plans and results, and design issue logging and resolution.
  • Knowledge of high-speed serial interfaces like PCIe, USB, MIPI, or USB.
  • Knowledge of CMOS imagers and machine vision standards.
  • Knowledge of international compliance requirements for electronics and radios.
  • Ability to self-manage, plan, multitask, and work effectively in a multi-functional team.
  • Mentoring of junior engineers and technicians

Preferred Experience

  • Knowledge of high speed and high-density PCB layout, propagation and impedance calculations, and fabrication methods. PCB simulation knowledge a plus.
  • MS Electrical Engineering preferred.
  • BS Electrical Engineering considered with additional experience.


Posted: May 18, 2021, 9:39 am
Category : Technicians
Job Type : Contract-to-Hire
Id : 8309
Region : Twin Cities

As a Manufacturing Technician, you will be responsible for daily manufacturing issues from production documentation, production line programming and setup. Activities will include assisting new product introduction, SMT, AOI, Robots, XY Gantry, Vision, and programming.

We are looking for a Manufacturing Technician that is a self-starter, enjoys a fast phased dynamic environment and works well in a team environment. The ideal candidate needs to be a precision-oriented professional with the ability to work efficiently within manufacturing, whose primary function and role will deal with Manufacturing Support on every level. We offer an opportunity to contribute to an innovative, forward-thinking, customer focused team, competitive compensation, and excellent benefits.

Tasks:

  • Suggest and implement continuous improvement tasks for production processes and documentation.
  • Manufacturing fixture development.
  • Acting as a manufacturing operator as needed.
  • Evaluate existing manufacturing processes and workflows to identify areas that could benefit from changes and improvements.
  • Apply working knowledge of product and assembly to the manufacturing process.
  • Participate in brainstorming sessions and cross-departmental meetings.
  • Identify and propose solutions to existing manufacturing problems.
  • Repairing equipment
  • Responding to breakdowns
  • Investigating production problems
  • Responsible for the equipment maintenance
  • Responsible for creating work instructions for manufacturing employees.
  • Responsible for keeping process documentation up to date.
  • Responsible for the prototype builds thru the production process.
  • Open to support production on first- and second shift as needed.
  • Follow QMS Policies and Procedures

Skills and Requirements:

  • Engineering aptitude, High School Graduate.
  • 3-month manufacturing experience.
  • Strong analytical, data based, problem solving skills.
  • Proficient with Windows operating systems and Microsoft Office programs.
  • Autodesk Inventor experience preferred.
  • Programming experience preferred.
  • Machining experience preferred.
  • Electrical circuit knowledge preferred.


Posted: May 4, 2021, 9:38 am
Category : Machinist
Job Type : Permanent
Id : 8264
Region : Twin Cities

Seeking a Machinist to operate CNC milling/turning/grinding machine centers and/or manual machinery in order to perform routine or repetitive operations in a manner which consistently meets customer specifications, quality requirements, and production standards.

 

Qualifications:

  • Ability to set up CNC lathes and mills.
  • Ability to set up Manual Lathes, Grinders and Mills for Manual Machining operations
  • Ability to understand and interpret programs using Mastercam software.
  • Assist with fabricating new components per Engineering drawings
  • Ability to verify work using various measurement methods.
  • Assist with modifying components per drawings or engineering's instruction
  • Work on jobs according to due date as provided using scheduling system
  • Maintain shop cleanliness.
  • Operate equipment in a safe manner
  • Communicate with other shifts
  • Work from verbal and or written instructions or sketches
  • Report job progress using current scheduling system
  • Ability to use a CAD system when needed to verify drawings
  • Mentoring of new Machinists
  • Work over time as requested
  • Work other duties as assigned

 

Knowledge and Skill Qualifications:

  • Strong math skills including trigonometry and geometry
  • Ability to read and interpret engineering drawings
  • Working knowledge of GD&T
  • Good interaction skills
  • Ability to work with minimal supervision
  • Basic computer skills
  • Demonstrate good troubleshooting and problem solving techniques
  • Basic understanding & knowledge of Machine Shop equipment, machining & measuring processes
  • Two year Machine Tool diploma or degree or equivalent experience (preferred)

 

Experience with the following type of equipment would be a plus, but not a requirement of the position:

  • Twin spindle twin turret, Y axis, live tooling, Fanuc control, Daewoo, TT1800 lathe
  • Single spindle, single turret, Y axis, live tooling, Fanuc control, Daewoo, Puma 2000Y lathe
  • Single spindle, single turret, Y axis, live tooling, Mazak Lathe
  • Mazak Vertical Mill
  • Mazak Horizontal Mill
  • Haas Vertical Mill
  • Bridgeport and Hardinge for Manual Machining operations
  • Swiss Turning
  • Cylindrical Grinding
  • Twin spindle, twin turret, Mazak Lathe
  • Mill turn, Mazak Lathe


Posted: April 8, 2021, 1:09 pm
Category : Firmware Engineer
Job Type : Contract-to-Hire
Id : 8172
Region : Twin Cities

Seeking a highly collaborative and technical Software/ Firmware Engineer Lead to help bring state of the art medical devices to market. As the software/firmware lead you will plan and coordinate development activities to ensure projects are effectively executed by the SW/FW development team that reports directly to you. You will play a technical project role in developing SW/FW and its associated documentation per established quality system procedures in addition to mentoring and growing the SW/FW team. You will work in multi-disciplinary teams to meet product and project requirements; collaborating with engineers and business leaders from a variety of companies and industries.

DUTIES AND RESPONSIBILITIES:

  • Establish the plans, processes, standards, methods, and tools for the development and verification of medical device software in compliance with IEC 62304
  • Provide technical support and cost estimates to evaluate new business opportunities
  • Writes software requirements based on system requirements
  • Create and maintain software risk management documentation such as design FMEAs in accordance with ISO 14971
  • Develop quality assurance plans to ensure compliance with quality system requirements.
  • Leads software prioritization efforts and coordinates software activities in a team environment
  • Performs scheduling activities and communicates schedule to management and customers
  • Analyzes software requirements to determine feasibility of design within time and cost constraints
  • Coordinate and facilitate software team meetings
  • Consults with hardware engineers and other engineering staff to evaluate interface between hardware and software, and operational and performance requirements of overall system
  • Translates software requirements into software architecture and design
  • Consults with customer concerning maintenance of software system
  • Coordinates configuration and release of software
  • Lead and coordinate unit, integration, and software system test activities
  • Contribute to the continuous improvement of best practices and processes within the software team
  • Will supervise others members of the engineering staff. Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws.

QUALIFICATIONS:

  • Bachelor's degree in Computer Science/Engineering
  • Master's Degree in Engineering is a plus
  • Ten or more years of experience, preferable in the medical device field, including 5+years principally writing embedded software and 5+ years offering engineering leadership
  • Experience and desire to manage and develop people.
  • Experience utilizing IEC 60601, IEC 62304 (Class C), and ISO 13485 standards
  • Proficiency with two or more of the following programming languages: C, C++, Java, Java Script, HTML, C#, Python, Objective C
  • Real-time embedded systems development and debug of bare metal and RTOS platforms
  • Experience with wireless connectivity, preferably Bluetooth Low Energy is a plus
  • Understanding of basic electronics, computer architecture, microcontrollers, etc.
  • Excellent customer service skills, with an advanced understanding of internal and external customer relationship building
  • Excellent interpersonal and teamwork skills with the ability to influence, motivate, mentor, and direct team resources.
  • Ability to solve problems and implement solutions to complex problems with available resources
  • Excellent organizational, reasoning, planning, and motivational skills.
  • Good meeting practices (proper attendance, agendas, start/stop times, minutes, actions, and follow-through).
  • Self-starter; self-motivator; driven to complete projects while promoting team member success
  • Ability to adapt processes to improve inefficiencies and accelerate outcomes

COMPETENCIES:

  • Analytical--Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data; Designs work flows and procedures.
  • Design--Generates creative solutions; Translates concepts and information into images; Uses feedback to modify designs; Applies design principles; Demonstrates attention to detail.
  • Project Management--Develops project plans; Coordinates projects; Communicates changes and progress; Manages project team activities.
  • Interpersonal Skills--Focuses on solving conflict, not blaming; Maintains confidentiality; Listens to others without interrupting; Keeps emotions under control; Remains open to others' ideas and tries new things.
  • Teamwork--Balances team and individual responsibilities; Exhibits objectivity and openness to others' views; Gives and welcomes feedback; Contributes to building a positive team spirit; Put success of team above own interests; Able to build morale and group commitments to goals and objectives; Supports everyone's efforts to succeed.
  • Change Management—Develops implementation plans; Communicates changes effectively; Builds commitment and overcomes resistance; Prepares and supports those affected by change; Monitors transition and evaluates results
  • Diversity--Demonstrates knowledge of EEO policy; Shows respect and sensitivity for cultural differences; educates others on the value of diversity; promotes a harassment-free environment; Builds a diverse workforce.
  • Ethics--Treats people with respect; Keeps commitments; inspires the trust of others; Works with integrity and ethically; Upholds organizational values.
  • Strategic Thinking--Develops strategies to achieve organizational goals; Understands organization's strengths & weaknesses; Analyzes market and competition; Identifies external threats and opportunities; Adapts strategy to changing conditions.


Posted: February 11, 2021, 12:47 pm
Category : Quality Manager
Job Type : Contract-to-Hire
Id : 7993
Region : Twin Cities

We are seeking an experienced Quality and Documentation Manager to help redevelop and maintain our ISO 9001 quality management system, quality assurance as well as documentation control.

Responsibilities:

  • Work with management, engineers and floor employees to assess current engineering and production practices and improve as necessary.
  • Drive design/process capability evaluation
  • Develop quality metrics for our products and processes
  • Manage Engineering change orders and process changes, receiving inspection/Final inspection process/documentation, CoCs, deviations, internal and external corrective actions and audits.
  • Responsible of the Documentation Control and Quality Management System policies and procedures.

Qualifications:

  • B.S. in Quality, Manufacturing, Business Administration or equivalent
  • A minimum of 5 years related experience required.
  • Contract manufacturing, ISO 9001, ISO 13485, IATF 16949 experience required
  • Quality and Documentation Control Management expertise
  • Quality Assurance expertise
  • Excellent communication skills


Posted: September 21, 2020, 1:41 pm
Category : Software Engineer
Job Type : Contract
Id : 7965
Region : Twin Cities

Looking for a Software Engineer to develop and support existing machine vision inspection systems and custom automated control systems used in the development and production of medical devices. Will work within equipment/software engineering group to design machine vision systems, including concept, plans, programming, and troubleshooting for complex manufacturing and test equipment. Requires BS (CS or EE) and prefer 3 - 5+ years of experience with automated equipment development, including some hands-on vision system knowledge. Must have strong experience with .NET and C# programming and understanding of automated equipment design. Prefer experience with SQL and Cognex Vision system development. Exposure to robotic systems a plus.

 

Job Responsibilities:

  • Investigate machine vision software to identify opportunities to increase yields and/or quality of the vision system.
  • Determine root cause with regard to machine vision inspection issues.
  • Update machine vision software for enhancements and bug fixes of existing systems.
  • Investigate machine vision lighting solutions to enhance existing inspection systems.
  • Collect and analyze inspection results to prove robustness of vision system changes.
  • Integrate machine vision software system into a PC or PLC based system.
  • Troubleshoot machine vision and controls systems using pneumatic and electrical schematics.
  • Develop/Update departmental standards.
  • Create supporting design documentation.
  • Make software modifications to existing automated controls equipment.
  • Follow departmental procedures and processes when updating and developing new systems.
  • Participate on project teams to develop clear specifications, evaluate feasibility of concepts, and provide estimates for electrical/software designs.
  • Communicate costs and project status to project lead.
  • Creates electrical/software designs utilizing the departments' standard development tools and procedures.

 

Posted: July 31, 2020, 1:48 pm
Category : Sales
Job Type : Permanent
Id : 7488
Region : Twin Cities

Development Resource Group is a fast-paced, well-established engineering staffing firm seeking a motivated and energetic individual to join our growing recruiting team. Development Resource Group has been supplying contract and direct hire technical staffing since 1986 specializing in Medical Device, Engineering, R&D, and Product Development.

DRG specializes in placement of hardware, software, and mechanical engineering personnel on projects with many high tech product development companies in the Twin Cities. Our engineers are responsible for design, programming, and testing of products for medical device, electronic products, and automation systems.

The Technical Recruiter must have excellent communication skills, a high level of computer system knowledge, and preferably direct experience in sourcing, interviewing, and placement of high-level product development engineers.

We are seeking an individual to manage the full recruiting lifecycle: sourcing, screening, interviewing, reference checking, and negotiating employment terms. The candidate will be well versed in all aspects of professional recruiting, including networking and the recent trends in hiring.

Ideal candidates will be skilled in the use of applicant tracking systems and be self-sufficient in navigating and administering the applicant flow process.

Prefer BS degree, with proven track record of success in the staffing industry.

We offer excellent earning potential, a competitive benefit package, and an opportunity to be successful in the fast-paced, growing technical staffing industry.


 

Posted: September 6, 2018, 9:34 am
Category : Sales
Job Type : Permanent
Id : 7487
Region : Twin Cities

Development Resource Group is a growing Technical Staffing firm located in Mounds View, MN. Since 1986, DRG has been assisting clients in locating experienced engineers for project-based work on a temporary, contract-to-hire, or permanent basis. We specialize in placement of hardware, software, and mechanical engineering personnel with a strong base of high tech product development companies in the Twin Cities. Our engineers are responsible for design, programming, and testing for medical device products, electronic products, control products and automation systems.

We are seeking a motivated and energetic individual to add to our Sales Team as an Account Representative. Account Representatives are responsible for working with our clients in establishing their needs and then working with our recruiting staff to fill those needs. Additionally, they support all contracted staff though the duration of their project, working to ensure both client and contractor's satisfaction. Candidates must have excellent communication skills, a high level of computer systems knowledge, technical staffing experience, be self-motivated and enjoy working in the "people business." A college degree is preferred, with several years of staffing sales experience and/or recruiting experience in a Technical or Engineering field.

We offer an enjoyable working environment with a proven track record in our industry, excellent earning potential, a very competitive benefits package and an opportunity to be successful in the fast-paced, growing technical staffing profession.



Posted: September 6, 2018, 8:20 am