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Development Resource Group

Get updates on all the job openings from Development Resource Group.

Category : Quality Engineer - Medical Device
Job Type : Contract
Id : 8023
Region : Twin Cities

Seeking a Quality Engineer to consult with Manufacturing, Information Management, Research Development & Engineering, Quality Assurance Operations and Product Performance Analysis teams to ensure compliance to company software development procedures and industry regulations. Review and approve deliverables of the software development lifecycle. Lead teams in performing Hazard Analysis. Occasionally assist teams in developing Standard Operating Procedures and Work Instructions for software development activities that meet their specific needs. Occasionally provide training for select software development activities. Occasionally write and execute test protocols and reports. 0-3 years experience required.



Posted: October 20, 2020, 10:05 am
Category : Software Engineering
Job Type : Permanent
Id : 8033
Region : Twin Cities

We are looking for a Senior Embedded Software Engineer to join our software team. A Senior Embedded Software Engineer is responsible for the architecture and implementation of embedded software for sensors. A Senior Software Engineer generally works at the direction of a Software Architect or Systems Engineer.

Core Responsibilities:

  • Design and implement embedded software for various sensor projects including new product development.
  • Design and implement unit tests and stress tests for validation of embedded software.
  • Document firmware architecture and communications interfaces.
  • Work closely with Electrical Engineering to debug and troubleshoot PCBA’s during board bring up, utilizing electronics troubleshooting tools such as logic and protocol analyzers and oscilloscopes.
  • Work closely with Software Engineering as they develop PC applications to control the sensors.
  • Provide support for legacy sensors, including designing and implementing solutions to challenges found in the field.

Experience, Education and Competencies Required:

  • BS Degree in Computer Science or Electrical Engineering (or similar).
  • 5+ years developing applications on custom electronic hardware.
  • Proficiency in C and C++ programming on embedded systems.
  • Strong electrical background and proficiency in reading electronic schematics, component datasheets.
  • Working with multi-discipline engineering teams throughout all phases of development.

Preferred Experience:

  • Embedded Linux development using Yocto and Bitbake, including driver development, integrating patches, Bitbake layer and recipe generation, and U-Boot.
  • Real time (super loop) firmware for micro-processors using SPI, I2C, UART, and SDIO to communicate with peripheral sensor IC’s.
  • Wireless communication protocols Bluetooth classic and WiFi (TCP/IP).
  • Wired communication over USB and Ethernet.
  • Image processing and other digital signal processing in an embedded environment.
  • Git and Microsoft TFS version control.


Posted: October 19, 2020, 1:58 pm
Category : Quality Engineering
Job Type : Contract
Id : 8031
Region : Twin Cities

Seeking a Quality Engineer to provide Quality Engineering support to product development teams ensuring delivery of highest quality product to the customer. This position will work effectively with company’s international site to support product transfer. The ideal candidate will use a wide application of technical principles, practices, and procedures. Will need a strong understanding of business unit function and cross group dependencies/relationships.

MAIN RESPONSIBILITIES & SPECIAL REQUIREMENTS:

  • Quality project support of Valve sewing, testing, and sterilization operations.
  • Supports and maintains the quality system and is able to make quality system recommendations and follow through to implementation to address issues found (CAPA, NCMR).
  • Establishes priorities of work assignments. (Decision Making/Impact) Exercises judgment in selecting innovative, practical methods to achieve problem resolution.
  • Author, review and execute IQ, OQ, PQ, PPQ, MVP, and IQA for new equipment and when changing existing manufacturing equipment.
  • Provide guidance for alignment with ISO13485 and FDA 21 CFR 820 Develop Gage R&R documentation for manufacturing processes, systems, and equipment. Develop, execute, and review test methods validation and design verification test plans. Act as a liaison between Management and other teams supporting TMV activities.
  • Develops and implements product quality plans, documents and systems by creating product specifications, quality specifications, quality plans, risk analyses, FMEAs in conjunction with other product development team members.
  • Creates Quality Tools & Training Materials by applying body of knowledge/expertise and communicating to respective teams.
  • Participates in determining goals and objectives for projects. Influences middle management on technical or business solutions.


Posted: October 19, 2020, 9:37 am
Category : Project Manager
Job Type : Contract
Id : 8030
Region : Twin Cities

Seeking a Program Manager to oversee and manage the operational aspects of the Neuro EU MDR project(s) related to Risk Management and serves as liaison between project management and planning, project team, and line management for a major medical device company. This position Manages the development and implementation process of a company's products and services involving departmental or cross functional teams focused on the delivery of existing products undergoing EU MDR certification.

Specifically, to Risk Management deliverables:

  • Reviews status of project deliverables and budgets
  • Manages schedules and prepares status reports.
  • Monitors the project from initiation through delivery.
  • Assesses project issues and develops resolutions through facilitating collaboration with Risk Therapy Managers, Process Owner, and cross functional partners to meet productivity, quality, and client satisfaction goals and objectives.
  • Develops mechanisms for monitoring project progress and for intervention and problem solving with project managers, line managers, and clients.

DIFFERENTIATING FACTORS

  • Autonomy: Manages experienced professionals who exercise latitude and independence in assignments. Provides tactical and / or operational leadership. Receives assignments in task and objective oriented terms.
  • Organization Impact: Strive for continuous improvement and consistency in deliverables. Establishes operational plans and implements policies and strategies. Decisions impact program schedules, customer satisfaction levels, or allocation of time, material resources, expenditures and funds.
  • Innovation and Complexity: Proposes modifications to functional operating policies and day to day processes. Problems and issues faced are complex, difficult and undefined, and require detailed information gathering, analysis and investigation to understand the problem.
  • Communication and Influence: Communicates with internal and external customers and vendors regarding ongoing operations. Uses information exchange, influence and active persuasion without direct exercise of command to gain cooperation of other parties . May interact on issues that have externally shared objectives.
  • Leadership and Talent Management: Manages a team consisting of supervisors and / or experienced professionals in the Specialist career stream. Leads, directs and reviews the work of a team who exercise latitude and independence in their assignments.
  • Required Knowledge and Experience: Requires practical knowledge in leading and managing the execution of processes, projects and tactics within one job area. Typically has advanced knowledge and skills within a specific technical or professional discipline with understanding of the impact of work on other areas of the organization. Has domain knowledge in: Risk Management / Safety, Remediation efforts, regulated environments, and is familiar with EU MDR regulations.Requires a University Degree and minimum of 4 years relevant experience, or advanced degree with a minimum of 2 years prior relevant experience.


Posted: October 15, 2020, 8:34 am
Category : Reliability Engineer
Job Type : Contract
Id : 8029
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 for a major medical device company.

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


Posted: October 14, 2020, 6:13 am
Category : Quality Engineering
Job Type : Contract
Id : 8027
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 decisionmaking.
  • 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 13, 2020, 6:17 am
Category : Manufacturing Engineer
Job Type : Contract
Id : 8026
Region : Twin Cities

Seeking a Sr. Manufacturing Engineer to design and develop manufacturing processes, tooling, and fixtures in order to meet daily production schedules while enhancing productivity and product quality.

Essential Functions:

  • Manage projects which include new production equipment, process improvements and cost reductions while supporting new product introductions.
  • Provide guidance to other engineers and technicians.
  • Additional responsibilities include:
  • Provide technical mentorship to engineers and technicians
  • Conduct Process FMEAs and Process Validations Improve product quality, labor efficiency, and throughput through the use of Lean manufacturing concepts
  • Coordinate the design, procurement, build and debug of tooling, machinery and test equipment
  • Work with Product Development to ensure Design for Manufacturability
  • Individual should:
  • Be innovative, resourceful, and work with minimal direction
  • Have excellent organization, problem solving, communication, and team leadership skills
  • Work effectively with cross-functional teams

Other Duties:

  • 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


Posted: October 12, 2020, 7:15 am
Category : Quality Engineering
Job Type : Contract
Id : 8025
Region : Twin Cities

Looking for a Product Stewardship Engineer to support the implementation of a product stewardship database for a major medical device company.

POSITION RESPONSIBILITIES:

  • Ensure part, packaging and product information is accurately tracked in database
  • Work to Corporate Regulatory/Product Stewardship team and provide updates as needed
  • Ensure compliance with geography specific restricted substance requirements (e.g., RoHS, REACH, EU MDR) and Restricted Substance Management (RSM) requirements
  • Facilitate, track and work with various groups on component changes in the manufacture, import and distribution of any new product or relocation of manufacturing processes
  • Facilitate division compliance with all RSM reporting requirements
  • Coordinate with R & D, support the implementation and integration of RSM evaluations
  • Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS) 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.
  • Supports Environmental Management System, ISO 14001 and division sustainability efforts.
  • Performs other related duties and responsibilities, on occasion, as assigned.

POSITION REQUIREMENTS:

  • Education: 4 year degree
  • Medical device manufacturing experience preferred
  • Experience in restricted substance management (e.g., REACH, RoHS) preferred
  • Experience working in a broader enterprise/cross-division business unit model preferred.
  • Must possess critical thinking, problem solving and planning skills.
  • Must use sound judgement and ability to build and maintain relationships with individuals and in teams.
  • 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.


Posted: October 12, 2020, 7:12 am
Category : Manufacturing Engineer
Job Type : Contract
Id : 8022
Region : Twin Cities

The Manufacturing Engineer will exercise knowledge of technical skills and understanding of the business objectives, manufacturing operations and dynamics of the company’s environment to take an effective and proactive leadership role in a specific technical manufacturing discipline. Set direction for, lead, and take ownership of complex manufacturing engineering technical tasks. These tasks may have multiple inter-coordinating elements. Expectation that the individual will be able both to anticipate and identify key issues and make recommendations for resolution where precedent may not exist and creative thinking is required. Resolution may involve the application of new methods and approaches and may require the consideration of impact with other system components. Interaction with peers and mentors on the individual’s projects is generally in the context of peer review to confirm the rationale for task approach direction as well as peer review of verification/validation activities.

Requirements: Bachelor Science or Bachelor Engineering, Electrical, Software, or Mechanical Engineering. Curriculum trains students in skills required to perform assignments. The individual will typically have had a minimum 2-5 years’ experience in an engineering discipline or advanced education to achieve the level of skill.



Posted: October 9, 2020, 2:03 pm
Category : Quality Engineering
Job Type : Contract
Id : 8020
Region : Twin Cities

The Design Assurance Engineer works closely with development/manufacturing/quality engineering to ensure compliance with the quality system. You will work closely with Regulatory Affairs personnel (internal or external) to monitor regulatory compliance. You will monitor quality assurance efforts to ensure that the company’s products conform to quality standards. You will partner with research/development and manufacturing engineering during new product start-ups and establishes checkpoints for testing new products and processes. The design assurance engineer is responsible for following established GMP/ISO compliant quality system practices.

Essential Functions:

  • Ensure company’s adherence to the established Quality System and GMP/ISO standards, including ongoing establishment and improvement to the quality system procedures.
  • Lead design assurance activities in support of development for electromechanical systems that utilize microcontroller technology, customized/off the shelf PCBs and software applications.
  • Manage new product Design History Files.
  • Work with Engineering, Marketing, Manufacturing and Regulatory to establish measurable, valid product requirements.
  • Aide in definition of test equipment as required to accomplish quality responsibilities.
  • Develops and documents test plan protocols, test procedures, and test reports.
  • Perform tests according to various protocol requirements. 8. Lead completion of risk management and risk analysis including FMEA.
  • Devise design verification and design validation plans for products based on performance specifications and risk analysis
  • Analyze and communicate conformance to specifications and standards.
  • Conducts technical and statistical investigations concerning compliance to specification and optimization of design relevant to specification.
  • Support completion of in vitro testing including applicable animal studies.
  • Aide in definition of supplier quality specifications, sampling plans, and vendor qualification.
  • Assist in specifications and testing of sterilization methods.
  • Lead system and product continuous improvement teams.
  • Reviews Engineering Change Orders, as required.
  • Perform other duties and responsibilities as assigned by senior management.


Posted: October 9, 2020, 8:53 am
Category : Mechanical Designer
Job Type : Contract
Id : 8016
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, 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: October 7, 2020, 2:41 pm
Category : Software Engineer
Job Type : Contract
Id : 8015
Region : Twin Cities

The Software Engineer is responsible for the analysis, specification, design and verification of software for medical applications in a regulated environment using standard software engineering tools and methods. A successful candidate is self-motivated and is able to work in a team environment.  The successful candidate is a continuous learner and strives for continuous improvement.

 

POSITION RESPONSIBILITIES:

  • Understand and follow the company's Quality System Policies
  • Specifies, designs, documents and verifies embedded SW for medical devices in a regulated environment using standard SW engineering tools and methods
  • Develops and implements verification designs based on requirements and specifications
  • Designs, debugs and tests own software and software developed by others
  • Provides ongoing status updates
  • Identifies opportunities for productivity and quality improvements
  • Implement (using TCL & C) test scripts and execute the test scripts in simulation
  • Analyze data and author test reports

 

BASIC QUALIFICATIONS:

  • 2+ years of job-related experience with Bachelor's Degree
  • 0-2 years of job-related experience with Master's Degree

 

PREFERRED QUALIFICATIONS:

  • Experience in translating design requirements to test requirements.
  • Experience in test design
  • Experience in the C, TCL, or C#
  • Experience in working in both Windows and LINUX environments
  • Experience in configuration and change management tools
  • Experience of working within a team to accomplish team and individual goals

 

Posted: October 7, 2020, 12:45 pm
Category : Quality Engineering
Job Type : Contract
Id : 8014
Region : Twin Cities

Seeking a Quality Engineer to initiate medical device quality assurance activities for a major medical device company. These activities must be in accordance with FDA Quality System Regulation, ISO13485 and other international standards. This position will also support device complaint investigation and failure analysis as required.

Essential Duties and Responsibilities:

  • Develop incoming inspection processes and document incoming inspection activities.
  • Provide in-process QA support to include inspection and document review.
  • Complete final acceptance activities.
  • Manage the sterilization process, including validations and product sterile loads.
  • Track nonconforming material and lead Material Review Board (MRB) efforts.
  • Interface and take lead QA role in interactions with suppliers, contractors and consultants that supply components, subassemblies and contract processing.
  • Lead complaint investigations on returned product.
  • Manage corrective action and quality improvement activities.
  • Manage aspects of internal quality system relating to receiving inspection, calibration, MRB, etc.
  • Assist in the performance of quality system internal auditing.
  • Support quarterly management review meetings.
  • Establish, monitor and evaluate quality system metrics.


Posted: October 6, 2020, 10:49 am
Category : Sales Engineer
Job Type : Permanent
Id : 8013
Region : Twin Cities

Seeking an Applications Engineering Manager to lead the Sales Applications Engineering team (5-7 members) as a key part of the sales group. This includes managing, coaching, training, strategic quoting and also performing some Applications Engineering functions (player/coach role) in a manner that will positively impact successful sales pursuits and help the team achieve sales goals, customer satisfaction and enhance the reputation of the company.

Qualifications:

  • Bachelor’s degree or equivalent in engineering or suitable physical science degree.
  • At least 5 years of experience in a sales and application engineering sales support capacity, most of which should involve automation and/or electro-mechanical products.
  • At least 1 year of experience in a supervisory role. Ability to lead and influence others in a confident, positive and results-oriented manner. Ability to identify and organize effective training to continue to enhance the team’s skill set.
  • Experience in sales or sales support to design, specify and quote new projects and tied to a sales target. Has significant experience making sales calls in the field and troubleshooting with customers on-site and over the phone/computer.
  • Desired functional knowledge of mechanical actuation and electrical motors or PLC programming.
  • Must exhibit a strong technical aptitude and ability to read and interpret engineering data as applicable to the company’s product line and an interest/ability to learn technologies and product.
  • Strong computer skills including the ability to use Microsoft Office based products, be familiar with some CAD drafting products and have an ability to learn some motor/drive programming.
  • Ability to communicate effectively, both verbally and in writing, with a wide variety of distributors, customers, prospects, company personnel and others. An ability to work effectively on the phone and video conferencing with a wide variety of sales people and customers in both a sales and troubleshooting capacity.
  • Ability to effectively train both internal employees and external customers.


Posted: October 6, 2020, 7:17 am
Category : BioMedical Engineer
Job Type : Contract
Id : 8012
Region : Twin Cities

The Senior Biomedical Engineer designs, develops and provides safety testing, repair, and maintenance of biomedical equipment. Ensures that the biomedical equipment is in compliance with applicable regulatory requirements and quality control standards. Design studies and conduct research on enzyme reactions and the effects of organic compounds on biological processes. Participate in activities such as compound screening and compound optimization programs, and developing and running enzyme assays.

  • 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 6, 2020, 6:23 am
Category : BioMedical Engineer
Job Type : Contract
Id : 8011
Region : Twin Cities

The Biomedical Engineer designs, develops and provides safety testing, repair, and maintenance of biomedical equipment. Ensures that the biomedical equipment is in compliance with applicable regulatory requirements and quality control standards. Design studies and conduct research on enzyme reactions and the effects of organic compounds on biological processes. Participate in activities such as compound screening and compound optimization programs, and developing and running enzyme assays.

  • 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 6, 2020, 6:15 am
Category : R&D Engineer
Job Type : Contract
Id : 8010
Region : Twin Cities

Looking for a talented R&D Engineer to be responsible for compliance with applicable Corporate and Divisional Policies and procedures. This position will also provide engineering support in the creation and the development of new medical device products (invasive and non-invasive).

  • Provides R&D support for MDR submission initiatives.
  • Provides R&D support for market-released cardiovascular catheters and introducers.
  • Conducts feasibility studies to verify capability and functionality to support investigations and/or design changes.
  • Develops solutions to improve product function and manufacturability.
  • Directs support personnel and coordinates project activities.
  • Write and submit Engineering Change orders.
  • Maintains detailed documentation throughout all phases of development.
  • Investigates and evaluates design changes, manufacturing changes, NCMRs and/or customer complaints.
  • Reviews or coordinates vendor activities to support development.
  • Research various cost-effective, alternative approaches to current designs and processes.

Requirements:

  • 1-5 years of related work experience
  • Prior engineering skills/experience preferred
  • Bachelor's degree in Mechanical, Biomedical or Electrical Engineering or an equivalent combination of education and work experience


Posted: October 5, 2020, 2:48 pm
Category : R&D Engineer
Job Type : Contract
Id : 8009
Region : Twin Cities

Looking for a talented R&D Engineer to be responsible for compliance with applicable Corporate and Divisional Policies and procedures. This position will also provide engineering support in the creation and the development of new medical device products (invasive and non-invasive).

  • Provides R&D support for MDR submission initiatives.
  • Provides R&D support for market-released cardiovascular catheters and introducers.
  • Conducts feasibility studies to verify capability and functionality to support investigations and/or design changes.
  • Develops solutions to improve product function and manufacturability.
  • Directs support personnel and coordinates project activities.
  • Write and submit Engineering Change orders.
  • Maintains detailed documentation throughout all phases of development.
  • Investigates and evaluates design changes, manufacturing changes, NCMRs and/or customer complaints.
  • Reviews or coordinates vendor activities to support development.
  • Research various cost-effective, alternative approaches to current designs and processes.

Requirements:

  • 1-5 years of related work experience
  • Prior engineering skills/experience preferred
  • Bachelor's degree in Mechanical, Biomedical or Electrical Engineering or an equivalent combination of education and work experience



Posted: October 5, 2020, 2:44 pm
Category : Electrical Engineer
Job Type : Contract
Id : 8004
Region : Twin Cities

The Electrical Engineer applies advanced engineering and scientific principles to the evaluation and solution of technical problems within the electrophysiology medical device market. Performs technical studies in support of project goals. Remains abreast of and consults on technical advancements. Identifies and routinely uses the most effective, cost efficient and best practices to execute processes; continually evaluates their effectiveness and appropriateness. Initiates the planning, organizing, performing, coordinating and/or directing of engineering work.

 

Duties:

  • Researches, designs and/or leads the analog and digital hardware systems for a variety of prototype devices, tools and fixtures based on project needs
  • Conducts evaluations, tests and analyses related to feasibility and function.
  • Performs troubleshooting and fault isolation activities on a variety of products and prototypes.
  • 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.
  • Documents custom tools with specifications, schematics and mechanical layouts to support document control and tool release.
  • Documents activities, including designs and design concepts, to support successful project transfers from research to product development programs.
  • Stays informed and up to date on technological developments within the electrophysiology (EP) medical device industry and competitive environment to identify opportunities that align and support organizational strategy.
  • 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.
  • Performs other related duties and responsibilities, on occasion, as assigned.

 

Requirements:

  • Bachelor of Science in electrical/electronic engineering or related engineering field.
  • 8+ 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 understanding of high speed signal integrity and EMI mitigation techniques.
  • 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.
  • 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.
  • Prioritizes and meets deadlines in an effective manner.
  • Strong organizational and follow-up skills, as well as attention to detail.
  • Ability to travel approximately 10%, including internationally.


Posted: September 24, 2020, 8:13 am
Category : Manufacturing
Job Type : Contract-to-Hire
Id : 8002
Region : Twin Cities

We are seeking an experienced, high caliber Process Development / Operations Excellence (OpEx) Engineer to focus on Tissue Heart Valve manufacturing and inspection continuous improvement (CI) and “Return to Green” (RTG) projects. The position will work very closely with cross-functional engineering line owners and the line experts/operators on the floor to manage initiatives for improvement of existing manufacturing processes, inspection processes, tooling, and fixtures to ensure product quality while enhancing productivity and reducing scrap and cost.

The candidate should have a demonstrated record of implementing LEAN processes, working with R&D on specification assessments, working jointly with Quality for process and inspection improvements, working jointly with Regulatory on submission requirements and working with Finance to drive cost all while improving quality via RTG and CIP initiatives.

  • Manage projects which include process improvements, inspection improvements and cost reductions to enhance existing production and be proactive for improvements on new product introductions.
  • Provide guidance to other engineers, technicians, trainers, and sewing specialists.
  • Manage CI and RTG Projects
  • Additional responsibilities include:
  • Provide technical mentorship to engineers and technicians
  • Understand Process FMEAs and Process Validations
  • Improve product quality, labor efficiency, and throughput through the use of Lean manufacturing concepts and root cause investigation tools (e.g. DMAIC).
  • Individual should:
  • Be innovative, resourceful, and work with minimal direction.
  • Have excellent organization, problem solving, communication, and team leadership skills.
  • Work effectively with cross-functional teams.
  • Utilize Root Cause Problem Solving techniques and lead cross-functional teams to resolve product quality/scrap 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.
  • 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
  • Performs other related duties and responsibilities, on occasion, as assigned

Qualifications:

  • Tissue Heart Valve Clean Room Experience driving yield improvements, reducing cost, while increasing capacity.
  • Understanding of Business Excellence (BEX)/Operations Excellence (OPEX) – LEAN, 5S and other principles for Manufacturing, Quality and Product Design.
  • Mechanical or Industrial engineering degree required
  • 10+ years manufacturing/quality engineering experience with related interface with R&D
  • Strong analytical, problem solving and project management skills
  • Demonstrated record of implementing LEAN processes
  • Demonstrated leadership capability in team settings
  • 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
  • Ability to maintain regular and predictable attendance

Your preferred qualifications and education:

  • Medical device experience preferred
  • Previous close interface with R&D preferred
  • International manufacturing experience preferred
  • Experience working in a broader enterprise/cross-division business unit model preferred.


Posted: September 24, 2020, 7:43 am
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 : Material Manager
Job Type : Contract-to-Hire
Id : 7992
Region : Twin Cities

As a Manufacturing Engineer, you will be responsible for daily manufacturing from production documentation, programming, through production improvements. Activities will include new product introduction, SMT, AOI, Robots, XY Gantry, Vision, AI, programming. Along with 3D CAD design, method improvements, paperless manufacturing software, and Customer communication.

The ideal candidate will need to be a self-starter and enjoy working in a team environment. Our day starts with a team meeting and project updates. We're looking for a precision-oriented professional with highly developed leadership qualities and the ability to work efficiently within manufacturing. The successful candidate's primary function and the role will deal with the conception, CAD design, and development of new flexible circuit assemblies and equipment. We're looking for someone who enjoys contributing to an innovative, forward-thinking team and who can always keep the end-user in mind.

Tasks:

  • Implement Aegis paperless manufacturing software platform.
  • Implement traceability to the board level.
  • New product documentation for production.
  • New product 2D and 3D CAD and tooling.
  • New product programming including Printer, Pick & Place, Oven, AOI, ET, Robots, Etc.
  • Customer assistance in 2D & 3D CAD design & BOM structures.
  • Evaluate existing manufacturing processes and workflows to identify areas that could benefit from changes and improvements
  • Apply working knowledge of product design and assembly to the manufacturing process
  • Create processes and procedures to help the company meet budgetary goals as well as performance quotas
  • Design and develop new products and product mock-ups alongside the creative team
  • Participate in brainstorming sessions and cross-departmental meetings to ensure collaborating and cohesion
  • Establish an effective and efficient work sequence
  • Devise new solutions to existing manufacturing problems
  • Develop standardized design criteria across all product lines

Skills and Requirements:

  • Bachelor's Degree - Manufacturing Engineer
  • 2+ years' Manufacturing Engineering Experience. SMT Experience a plus.
  • Strong organizational, analytical, and communication skills
  • Proficient with Windows operating systems and Microsoft Office programs
  • Experience with 2D & 3D CAD required.
  • Experience with Programming required.


Posted: September 21, 2020, 1:38 pm
Category : Mechanical Engineer
Job Type : Contract-to-Hire
Id : 7991
Region : Twin Cities

Seeking a Mechanical Engineer responsible for designing new equipment and develop improvements for current equipment.

POSITION RESPONSIBILITIES:

  • Create and maintain BOMs and drawings for new and existing machinery
  • Create manufacturing drawings
  • Keeping engineering documentation up to date and organized
  • Repairing equipment
  • Investigating production problems
  • Making improvements to current operations to enhance efficiency
  • Follow Quality Management System policies and procedures.

POSITION QUALIFICATIONS:

  • B.S. Mechanical or equivalent
  • A minimum of 5 years related experience required.
  • AutoCad/Inventor expertise
  • Be able to perform hand calculations, including but not limited to, heat transfer, fluid dynamics and statics, mechanical stress and balance of masses and energies
  • Machining knowledge
  • Production environment knowledge


Posted: September 21, 2020, 11:02 am
Category : Software Engineer
Job Type : Contract-to-Hire
Id : 7990
Region : Twin Cities

Seeking a talented Software Programming Engineer to be responsible for developing and improving new processes on our robotic lines using the following languages; VB.Net, PacScript (Denso Robots), ACSPL+(ACS Motion Control), Mint(ABB Motion Control), Orion2, Microsoft Access)

POSITION RESPONSIBILITIES:

  • Process Control/ Implementation/Improvement.
  • Designing/managing/querying Microsoft Access Database.
  • Keeping programming documentation up to date.
  • Creating work instructions for manufacturing employees.
  • Investigating production problems.
  • Making improvements to current operations to enhance efficiency.
  • Maintaining statistical records and process control databases.
  • Follow Quality Management System policies and procedures.

POSITION QUALIFICATIONS:

  • B.S. Electrical Engineering /Data Science or equivalent.
  • A minimum of 5 years related experience required.
  • C, C#,Visual Basic Programming expertise.
  • Microsoft Access expertise, SQL knowledge.
  • Motion Control and Machine vision (Cognex) experience.
  • Familiarity with contract manufacturing environment.
  • CAD / Autodesk Inventor knowledge.


Posted: September 21, 2020, 10:59 am
Category : Packaging Engineer
Job Type : Contract
Id : 7989
Region : Twin Cities

Seeking a Packaging Engineer to be responsible for providing package engineering support in the creation, development and improvement for medical device packaging systems (invasive and non-invasive).

POSITION RESPONSIBILITIES:

  • Responsible for compliance with applicable Corporate and Divisional Policies and procedures
  • Researches, develops, designs, evaluates and documents packaging systems, materials, incoming receiving, distribution systems and packaging line equipment
  • Develops new concepts from initial design to market release
  • Directs support personnel, coordinates, and reports on project activities
  • Write and submit intellectual property (patents, when applicable)
  • Investigates and evaluates existing technologies for potential improvement or use
  • Reviews or coordinates vendor activities to support development and use.

POSITION REQUIREMENTS:

  • Bachelor's degree plus 6+ years of related work experience with a strong understanding of specified functional area, or an equivalent combination of education and work experience. 4
  • Advanced degree preferred.


Posted: September 21, 2020, 9:32 am
Category : R&D Engineer
Job Type : Contract
Id : 7987
Region : Twin Cities

Seeking an R&D Engineer with work on cardiac occluders and associated delivery system - remediation and continuous improvement activities for a major medical device company.

  • 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:

  • 3-7 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 nitinol a plus
  • Experience working with mechanical devices a plus
  • Working knowledge of the E.U. medical device regulation a plus


Posted: September 11, 2020, 11:06 am
Category : Electrical Engineer
Job Type : Contract
Id : 7982
Region : Twin Cities

Seeking a Sr. Electrical Engineer to be responsible for the development of new products, including electronic architecture design, detailed circuit design and analysis, prototyping, implementing designs, test, and discovering innovative solutions to complex problems and systems.

Primary Responsibilities:

  • Performs detailed electronic designs for electronic components, products, or systems for commercial, industrial, medical, military, or scientific applications.
  • Analyzes customer needs and determines electrical system requirements and cost to develop a system plan. Ability to evaluate current systems/processes to recommend design modifications or equipment repair/updates.
  • Develop testing procedures for electronic components and equipment; includes leading and supporting prototype build and test activities.
  • Writes technical documents such as design specifications, verification test plans and reports.
  • Plans and develops applications and modifications for electronic properties used in parts and systems to improve technical performance.
  • Develops reliable, cost effective, manufacturable electronic products from initial studying of customer requirements through conducting and documenting design validation and verification activities.
  • Performs circuit analysis, simulations and concept/feasibility design activities.
  • Conducts design analysis on components and/or assemblies.
  • Creates detailed block diagrams & circuit schematics.
  • Leads and/or supports printed circuit board layout and/or other product activities.
  • Practices good engineering design process; version control, lead design reviews, documented design history, complete projects within budgetary and scheduling goals.
  • Works and communicates with management team, engineering team, and/or project managers to ensure projects are completed satisfactorily, on time, and within budget.
  • Supports project planning and project proposal efforts.
  • Presents verbally in one-on-one or group settings.
  • Responsible for following all ISO quality systems and procedures.

Education/Experience:

  • Bachelor of Science in Electrical Engineering or equivalent; or five to ten years related experience and/or training; or equivalent combination of education and experience.
  • Experience with Altium schematic capture and PCB layout
  • Must have experience working with microprocessor-based platforms, analog and digital circuits, and experience with sensitive analog circuit design and analog design tools such as SPICE.
  • Knowledge of signal integrity concepts, simulation tools, and with compliance and regulations, i.e. IEC 60601-1 and ISO 14971 risk management, highly desired.
  • Bachelor's degree and experience in new product development, ranging from requirements development to prototyping, to verification and product release, preferred.
  • Experience in medical device and/or other regulated industries, and project management experience preferred.


Posted: September 3, 2020, 7:40 am
Category : Project Manager
Job Type : Contract
Id : 7715
Region : Twin Cities

Seeking a Project Manager to lead and ensure a successful execution and closure of assigned projects. The successful candidate will manage scope, schedule and budget of assigned projects. Be the single point of contact for all assigned customers projects and be Proactive Project Risk Mitigation.

Key Responsibilities:

  • Single point of contact for assigned projects from Order Launch through shipment.
  • Facilitate review of customer specifications and quotes such that the scope of work is defined.
  • Estimating, quoting, and documenting change(s) in scope to customer.
  • Direct communication to align and reconcile project expectations with deliverables.
  • Collaborate in assembling project financial plan, monitor the plan and drive for corrective action when plan is in jeopardy.

Additional Responsibilities:

  • Work with customers to correct measurable, significant lapses in plan.
  • Provide ongoing support after shipment as necessary, until customer is completely satisfied.
  • Arrange and facilitate all customer visits during duration of project.
  • Obtaining from customer all that is needed for our completion of project: specifications, test material,
  • floor plan sign offs, payments, etc.
  • Coordinates project work plan for successful project completion.

MINIMUM JOB REQUIREMENTS:

  • Bachelor’s degree in related field or equivalent experience
  • Experience in a fast paced, engineered to order, manufacturing environment
  • Five years of experience in a project management position.
  • Demonstrated technical competency with product line
  • Highly organized and good at managing details
  • Exceptional presentation skills
  • Aptitude to deal directly with customers effectively in high pressure situations, not conflict-adverse
  • Proactive on follow-up, not letting issues linger
  • Exceptional written and verbal communications skills
  • Proven ability to plan
  • Good negotiator (searches for “win-win” solutions)
  • PMP or similar certificate desirable


Posted: August 7, 2020, 11:25 am
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 : Electrical Engineer
Job Type : Contract
Id : 7964
Region : Twin Cities

Excellent opportunity for a Controls Automation Engineer to support design and programming of manufacturing / test equipment used in the development and production of medical device products. Requires BS degree (EE, CS) and experience in design and programming of complex industrial machine control systems. This includes PLC / HMI programming, control panel / hardware design, and system troubleshooting and start-up. 

  • Prefer 3 - 5 years of experience in automated system design.
  • Prefer experience with Allen Bradley/Rockwell Automation PLC and HMI, robotics, motion control, vision systems (Cognex) programming, and system validation and start-up.
  • Prefer experience with SAP and Manufacturing Execution Systems (MES).
  • Prefer experience working within an FDA (or similar) regulated validation and documentation process preferred, and experience with Visual Basic / .NET  programming and SQL database development is a plus.


Posted: July 31, 2020, 1:42 pm
Category : Test Engr - Technical
Job Type : Contract
Id : 7962
Region : Twin Cities

The Test Engineer in the Radio Quality function has primary responsibility for the planning and executing of wireless and telecommunications compliance testing to enable world-wide radio frequency approvals for company products. Under the general direction of the Radio Quality Manager, the Test Engineer in the Radio Quality group is responsible for working cross-functionally to understand device and instrument functionality, configure test samples, understand wireless and telecommunication requirements, and execute compliance testing, as well as planning and coordination of radio and telecommunication activities. In addition, the Test Engineer may review or develop compliance documentation, engineer test set-ups, and create procedures to support internal requirements.

Qualifications:

  • Basic knowledge of RF instrumentation and other electronic lab equipment such as spectrum analyzers, signal and waveform generators, oscilloscopes, power meters and sensors, and RF amplifiers.
  • Understanding of active implantable medical device functions and device programming at a system and firmware level.
  • Skills to interpret and understand regulatory requirements and standards.
  • Experience with test equipment, set-ups and test methods used to assess wireless and telecommunications compliance.
  • Operation of medical device programmers and associated instruments.
  • Knowledge and basic understanding of 50 ohm measurement systems, shielding and filtering.

Preferred Qualifications:

  • Familiar with radio and EMC regulations and standards such as US FCC, Canada ISED, European ETSI and Directives.
  • Experience in evaluating products which contain wireless and telecommunication systems.
  • Knowledge of wireless communication systems used in active implantable medical devices and instruments.
  • Working knowledge of LabVIEW and MATLAB.
  • Knowledge and basic understanding of electromagnetic interference (EMI) and electromagnetic compatibility (EMC).

Education:

  • 4 year degree in an electronics-related field such as Engineering Technology, Electrical Engineering, Systems Engineering, Computer Engineering or similar discipline.

Experience:

  • 3-5 years of experience with a desire to perform hands-on activities and interface with product development teams.


Posted: July 29, 2020, 12:28 pm
Category : Firmware Engineer
Job Type : Contract
Id : 7798
Region : Twin Cities

Seeking a Senior Embedded Software Engineer to design & develop reliable, maintainable, testable software for products used in a wide variety of applications based on 8/16/32/64-bit and multicore processors running no operating system to embedded RTOS, Linux, Windows, etc..

 

Responsibilities:

  • Participate in overall system design and analysis activities from new product concept and customer requirements to risk analysis to verification and validation.
  • Create, document and maintain software architectures.
  • Code, debug and test software on a wide variety of platforms and operating systems.
  • Write and maintain software specifications, plans and reports.
  • Follow documented software processes and contribute to continuous process improvement.
  • Work and communicate with leaders, engineers and project managers to ensure project completion.
  • Support project planning and project proposal efforts.
  • Present verbally in one-on-one or group settings.
  • Other duties as assigned.

 

Requirements:

  • Minimum Bachelor of Science in Electrical Engineering, Computer Science, Software Engineering or equivalent (Master's degree preferred).
  • Minimum 8+ years of experience in new product development.
  • Experience with the product development process ranging from requirements development, prototyping, verification and product release.
  • Must have significant experience developing software in C and/or C++ for embedded systems.
  • Experience with basic software and hardware debug tools (JTAG debuggers, oscilloscopes, etc.).
  • Experience working in teams with multiple engineering disciplines and external 3rd parties.
  • Strong verbal and written communication skills including the ability to write technical specifications and design documentation.
  • Ability to manage multiple priorities.
  • Ability to provide leadership and guidance to junior level staff.
  • Ability to work in a fast paced environment with quickly changing priorities.

 

Desired Experience:

  • Experience in medical device design or other regulated industries.
  • Working with implantable devices.
  • Leading software projects; i.e. project manager, project lead etc.
  • Managing project budget, schedule, progress towards milestones
  • Experience with software processes compliant with IEC 62304.
  • Writing and executing software unit, integration and verification tests.
  • Writing requirements from high level customer needs to detailed specifications.
  • Risk management activities compliant with IEC 14971.

 

 



Posted: July 15, 2020, 12:03 pm
Category : Firmware Engineer
Job Type : Contract
Id : 7930
Region : Twin Cities

Looking for a Senior Firmware Engineer to join our R&D Organization to design and develop new and modifications to firmware for the cardiac ablation systems. The Senior Firmware Engineer will also be responsible for designing test systems or subsystems for testing the equipment. 

Areas of responsibilities will include firmware system design, software development in C, design requirements, test requirements and test procedures, PC-based simulation and test automation in C#.Candidates must be able to translate design inputs into firmware design, write detailed firmware specifications, 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 also be willing to work in a fast paced, multi-tasking, team environment.

CVG, 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

  • The candidate must have the ability to work well with a variety of individuals ranging from various engineering disciplines (mechanical, electrical, and software) to marketing, clinical, reliability, regulatory and operations.
  • Design, develop, test, document, operate and maintain software and firmware components and computing systems software to be applied to and integrated with mechanical and electrical systems.
  • Applies 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

 

BASIC QUALIFICATIONS/EDUCATION/EXPERIENCE

  • 8+ years of embedded software design and development with Bachelors Degree in Engineering (Electrical or Software)
  • 6+ years of experience with Masters Degree or
  • 5+ years of experience with PhD
  • Embedded software development in C language
  • Strong experience working with hardware, including ability to read schematics, data sheets and interface specifications
  • Strong experience in technical specification and report writing
  • Must be able to mentor and review the work of less experienced engineers
  • Must be able to work with minimal supervision
  • Mastery of basic laboratory instruments and tools (e.g. DMM, oscilloscope, logic analyzer, spectrum analyzer)
  • Ability to work in a team environment; strong collaboration skills
  • Effective verbal and written communication

 

DESIRED/PREFERRED QUALIFICATIONS

  • MS Software Engineering or Electrical Engineering
  • Experience with cardiac ablation products
  • Experience with ARM Cortex M processors (preferably STMicro)
  • Experience with real-time operating system (e.g. µC/OS-II, FreeRTOS)
  • Experience with IAR Embedded Workbench
  • Experience with TCP/IP communication and lwIP
  • Experience with Unity unit test framework
  • Experience with C#
  • Experience with embedded security (e.g. Secure boot, Chain of Trust, Authentication, etc.)
  • Specific knowledge of international medical device standards


Posted: June 26, 2020, 6:51 am
Category : Technician - Medical Equipment
Job Type : Contract
Id : 7856
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 enclosures, and PLC installations and check-out.

 

Preferred Skills:

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

 

Posted: February 28, 2020, 1:47 pm
Category : Technicians
Job Type : Contract-to-Hire
Id : 7776
Region : Twin Cities

Seeking a Production Technician to support Semiconductor sensor products.  The Production Technician will support engineering with moderately complex engineering duties and/or hands-on tasks. 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 is from 6:00am to 2:30pm with flexible hours to work outside of standard hours.
  • Other duties as assigned.

 

Experience, Education, and Competencies Required:

  • Two year technical degree in manufacturing or related field with two 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:
  • Five years of optics or semiconductor 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 4, 2019, 11:51 am
Category : Project Manager
Job Type : Permanent
Id : 7765
Region : Twin Cities

Seeking a Project Manager to be the primary customer interface during all project phases of design, supply, production, factory testing, delivery, install, and customer site acceptance testing. This individual will be responsible for project leadership on build to print and custom automation design and build projects.

Responsibilities:

  • Provide leadership to drive project related decisions (technical & non-technical)
  • Develop detailed project plans and specification documents
  • Identify resources by discipline required for successful project milestone deliveries.
  • Work with organization management on early identification and labor durations of project resources
  • Plan and lead all internal and customer project design reviews throughout project execution
  • Execute project plans which are designed to exceed financial targets
  • Manage quality, schedule, cost, and customer satisfaction
  • Manage contract compliance as it relates to "as sold" scope, allowable deviations, scope changes requiring purchase order adders, timely release of invoicing, and payment receivables

Requirements:

  • Ideal candidate will have the ability to manage multiple projects of varying degrees of complexity simultaneously, proven leadership, planning and organizational skills, and strong technical background in automation design.
  • Candidate must demonstrate proven "systems" approach to project management and the drive to consistently deliver on commitments.
  • Qualified candidate will have a BS or MS in Engineering or Technical discipline and 8-10 years of relevant experience. Significant team leadership experience, preferably in a project environment, is desired.



Posted: October 11, 2019, 11:09 am
Category : Controls Engineer
Job Type : Contract
Id : 7725
Region : Twin Cities

Seeking a Controls Engineer to develop control system design and application of various technologies including: multi-axis motion control, image processing, vision-guided robotics, industrial instrumentation & automatic control. This position will provide technical leadership in a team-oriented work environment, interface with customers on technical projects, system programming PLC/motion/vision, startup/commissioning of machine control systems.

Position Requirements:

  • BS or MS in Mechanical or Electrical Engineering with control system emphasis (min 3.2 GPA) and relevant intern or co-op experience.
  • Strong electromechanical aptitude.
  • Motion control/Robotics experience (Delta Tau, Adept, Yamaha, Epson).
  • PLC/PC programming experience (Allen-Bradley, GE Fanuc, etc.).
  • Vision experience (Cognex, DVT, Adept).
  • Solid organizational skills.
  • Strong desire to work in a fast-paced, entrepreneurial environment.
  • Ability to consistently deliver on commitments.


Posted: August 28, 2019, 12:46 pm
Category : Mechanical Engineer
Job Type : Contract
Id : 7657
Region : Twin Cities

 

Looking for a Mechanical Engineer to design medical devices to comply with industry methodologies and standards.  This candidate will define requirements, technologies, and methodologies for individual projects.  Research and analyze data such as experimental data, customer design proposals, specifications, and documentation.  Direct and coordinate actions from product conception through design transfer to ensure products and systems conform to engineering design, standards and customer specifications.  Resolve technical issues and problems.  Effectively communicate their work and status.  Delegate work and leverage engineering technicians and designers.

 

Requirements:

  • 3+ yeas of leading product design development.
  • 7+ years of direct experience with the product development process ranging from requirements development, prototyping, verification and product release.
  • Experience in medical device design or other regulated industries
  • 7+ years of leading/contributing completion of DHF document deliverables.
  • 7+ years of working in development of devices regulated under IEC 60601-1 standard
  • 3+ years working under ISO 14971 Risk Management for Medical Device Standard

 

Strong Candidate in addition to requirements:

  • 3+ years of planning, assigning, and directing work
  • Responsible appraising performance
  • 3+ years in contract manufacturing environment

 

Duties and Responsibilities:

  • Strong analytical and problem solving background.
  • Works with suppliers and manufacturing facilities to design for manufacturability.
  • Identifies and efficiently resolves technical problems and issue.
  • Leads and communicates to a client for small scale programs.
  • Researches and analyzes experimental data to understand design issues and set a direction for issue resolution.
  • Delegates and sets work direction for technicians and designers.
  • Creates test protocols and reports for verification testing.
  • Proficient in CAD (Solidworks preferred), Labview and general test and measurement equipment preferred.
  • Able to complete engineering tasks in a timely fashion, and manage time budgets for tasks.
  • Effectively communicates project technical status, time and schedule for tasks including estimates to complete.
  • Proficient with documentation control and change order process.

 



Posted: May 14, 2019, 11:46 am
Category : Controls Engineer
Job Type : Permanent
Id : 7556
Region : Twin Cities

Seeking a Systems Engineer to develop control system design and application of various technologies including: multi-axis motion control, image processing, vision-guided robotics, industrial instrumentation & automatic control. This position will provide technical leadership in a team-oriented work environment, interface with customers on technical projects, system programming PLC/motion/vision, startup/commissioning of machine control systems.

Requirements

  • BS or MS in Mechanical or Electrical Engineering with control system emphasis (min 3.2 GPA) and relevant intern or co-op experience.
  • Strong electromechanical aptitude.
  • Motion control/Robotics experience (Delta Tau, Adept, Yamaha, Epson).
  • PLC/PC programming experience (Allen-Bradley, GE Fanuc, etc.).
  • Vision experience (Cognex, DVT, Adept).
  • Solid organizational skills.
  • Strong desire to work in a fast-paced, entrepreneurial environment.
  • Ability to consistently deliver on commitments.


Posted: December 6, 2018, 9:22 am
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