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Development Resource Group

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Category : Quality Engineer - Medical Device
Job Type : Contract
Id : 7851
Region : Twin Cities

Seeking a Quality Engineer I to consult with Manufacturing, Information Management, Research Development & Engineering, Quality Assurance Operations and Product Performance Analysis teams to ensure compliance to 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. Experience required: 0-3 years.



Posted: February 24, 2020, 11:43 am
Category : Chemical Engineer
Job Type : Contract
Id : 7850
Region : Twin Cities


The Senior Chemical Engineer will participate on an R&D team developing medical devices for treating chronic end-stage kidney disease.  The main purpose of this role is to plan and execute R&D activities to design and develop a sorbent based water purification canister for dialysis therapy in accordance with established quality procedures.

 

Responsibilities:

  • Plan and conduct R&D activities to define requirements for the water purification module, identify and screen sorbent materials and develop prototype cartridges to demonstrate technical feasibility
  • Plan and prioritize project activities, develop a project schedule and execute project to meet the agreed upon schedule and budget constraints.
  • Identify and manage external R&D resources as needed to complete the project
  • Provide written and verbal project updates with manager, project sponsors and other stakeholders regarding project status, risks/issues and accomplishments
  • Provide input to departmental staffing needs and participate in staff hiring as needed
  • Identify opportunities to improve the product development process and proactively lead change as directed by manager

 

Qualifications & Experience:

  • BS in Chemistry, Chemical Engineering or related filed
  • 5+ years of engineering experience with preference to experience in medical device or other regulated industry
  • Demonstrated experience in the design and development of water filtration systems from concept through commercial readiness
  • Strong working knowledge of chemical sorbent and ion exchange materials
  • Working knowledge of plastic materials and processing techniques
  • Demonstrated experience in project planning and management
  • Proficiency in Microsoft Word, Excel, Project, PowerPoint, Visio
  • Self-starter with strong work ethic and initiative in accomplishing objectives
  • Strong organization and time management skills; ability to manage multiple priorities
  • Attention to detail, thoroughness
  • Strong written and verbal communication including ability to clearly articulate design concepts
  • Able to work in cross-functional and cross-cultural teams

 

Nice to Have:

  • Proven ability to work well in team environment, with sound negotiation and problem solving skills
  • Ability to lead, energize and influence change efforts at all levels of a complex organization
  • Demonstrated ability to get results through others not under direct supervision
  • Able to work under deadlines and handle multiple detail-oriented tasks simultaneously
  • Able to work independently and across different geographies.
  • Superior interpersonal, verbal and written communication skills; able to communicate effectively and interact with personnel at all levels of technical ability and expertise


Posted: February 24, 2020, 9:01 am
Category : Firmware Engineer
Job Type : Permanent
Id : 7848
Region : Twin Cities

We are looking for a Senior Embedded Software Engineer to be 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: February 21, 2020, 2:13 pm
Category : Systems Engineer
Job Type : Contract
Id : 7849
Region : Twin Cities

Seeking a Senior Systems Engineer to work within the Systems Integration and test team to perform integration planning, coordination, and testing of a new cloud based platform which provides the users with a web based interface to retrieve and store information from a company system. Platform includes both mobile applications and servers to combine data sets into a usable format. This individual will join a team to deliver a high quality product to the market on time and on budget.

POSITION RESPONSIBILITIES:

  • 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.

POSITION REQUIREMENTS:

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


Posted: February 21, 2020, 2:01 pm
Category : Project Manager
Job Type : Contract
Id : 7847
Region : Twin Cities

Looking for an Engineering Project Manager to lead remediation of medical device products for EU MDR compliance for a leading medical device manufacturer. You would be part of a core team responsible for the post-market compliance program and accountable to senior staff. This position in based in Mounds View, MN and local candidates are preferred.

 

POSITION RESPONSIBILITIES:

  • Lead cross functional teams to remediate product technical files for compliance with the new EU MDR.
  • Assess project issues and develop solutions to meet quality, timing, and budget goals and objectives.
  • Oversee and manage the operational aspects of ongoing projects and serve as liaison between project management and planning, project team, and line management.
  • Manage the development and implementation process of products involving departmental or cross-functional teams focused on the delivery existing products under the new EU MDR.
  • Review status of projects and budgets; manage schedules and prepare status reports.
  • Monitor the project from initiation through delivery.
  • Develop mechanisms for monitoring project progress and for intervention and problem solving with other project managers, functional managers, and subject matter experts.
  • Communicate with stakeholders and obtain stakeholder engagement to ensure the required people and other resources are available and committed to meeting project needs.
  • Autonomy: Manages one or more small-scale, developed or mature programs with well-defined program plans and delivery methodologies.  Is accountable for overall program process, performance, and customer satisfaction.
  • Organizational Impact: Provides input to establishing program objectives, timelines, milestones, and budgets .  Recommends new policies and procedures that affect program management. May have budget accountability for one or more programs. Program decisions are generally made only after consultation with higher level management.
  • Innovation and Complexity: Problems faced are difficult, and require detailed information gathering, analysis and investigation to understand the problem. Problems typically impact multiple workstreams, departments or specialties .  Modifies programs management processes to improve program.
  • Communication and Influence: Communicates and leads meetings with internal and external customers and vendors, conducts briefings to higher level management team.  Solves issues through information exchange, influence and active persuasion without direct exercise of command to gain cooperation of other parties on program execution plans.
  • Leadership and Talent Management: Leads, directs and reviews the work of a team of professionals and/or vendors who exercise latitude and independence in their assignments.  Direct involvement in daily tasks necessary for successful program execution. Not directly responsible for hire or fire decisions and people management.

 

POSITION REQUIREMENTS:

  • Requires a Baccalaureate degree (or for degrees earned outside of the United States, a degree which satisfies the requirements of 8 C.F.R. • 214.2(h)( 4)(iii)(A) and minimum of 5 years of relevant experience, or advanced degree with a minimum of 3 years of relevant experience.
  • Engineering project management experience in the medical device field preferred.


Posted: February 19, 2020, 9:16 am
Category : Drafter
Job Type : Contract
Id : 7846
Region : Twin Cities

We are seeking a CAD Drafter to join our Shared Services CAD team. The primary function of this position is to support Engineering and Manufacturing by working with Engineers and Technicians in the creation and revision of CAD models for devices, fixtures, and tooling. They should also have file vaulting background with such interfaces as Work Group Manager or EPDM. Be able to easily identify and maintain CAD file relationships.

  • Drafter/ Designer- Solidworks
  • PDM System Experience- Windchill PDM Link
  • 3+ years of experience
  • Certificate/ Diploma/ AS in Design/ Drafting
  • Design Validation Tools experience- Collision detection, interference, thinness analysis
  • Advanced modeling technique, surfacing, sheet metal, design tables
  • Machining, manufacturing experience preferred
  • Injection molding, CNC machining experience, laser cutting/ welding


Posted: February 12, 2020, 1:57 pm
Category : Quality Engineering
Job Type : Contract
Id : 7845
Region : Twin Cities

We are seeking an experienced, high caliber Sr. Design Assurance Quality Engineer. The Development Quality team is involved in product development, test method validation, design verification and validation (including hands-on test execution), and sustaining design support.

Position Responsibilities:

  • Lead on-time completion of Design Control Deliverables
  • Drives design quality, reliability, and compliance to standards and regulations
  • Brings electrical and hardware expertise to the product development process
  • Works closely with program teams to ensure timely and accurate completion of Quality deliverables
  • Accountable for Design Verification and Validation planning & execution, including active cross-functional root-cause analysis investigation & resolution activities
  • Work closely with design test and inspection method development, and lead test method validation activities
  • Ensure DHF content completion, integrity, and regulatory & standards compliance; collaboratively communicating & resolving gaps
  • Support and ensure the establishment of objective, measurable, discrete, and verifiable customer and product requirements
  • Builds a strong collaborative partnership with Research & Development to ensure cross-functional customer needs are met without creating barriers to development cost, time and scope
  • 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.

Position Requirements:

  • Bachelor level degree in Electrical or Electronics Engineering, System Engineering or equivalent; advanced degree preferred.
  • Minimum 5 years of experience in a degree-related field
  • Experience with analog/digital circuit design and analysis, plus knowledge of electronic instruments
  • Experience with product development (in a Development or Quality role), test method development and validation, test execution, failure analysis and risk management
  • Project management and leadership skills, including the demonstrated ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner
  • Ability to work in a highly matrixed and geographically diverse business environment and able to follow direction

Preferred qualifications and education:

  • Advanced degree in Electrical, Electronics or Systems Engineering
  • Experience in the implantable medical device field
  • Experience with EMI/EMC, Coexistence, and/or MR environment exposure on active implantable medical devices (simulation and testing)
  • Familiarity with FDA/ ISO and IEC standards and regulations
  • Prior design and development experience in the related field
  • Statistical method and Critical to Quality training and experience
  • Root cause analysis and Finite Element Analysis experience
  • ASQ CQE or other professional certifications
  • Experience working in a broader enterprise/cross-division business unit model


Posted: February 12, 2020, 8:18 am
Category : R&D Engineer
Job Type : Contract
Id : 7842
Region : Twin Cities

Seeking an Experienced R&D Engineer - Human Factors to apply human factors and ergonomics expertise to the definition, design, and evaluation of products within the R&D division of a leading Medical Device company.

POSITION RESPONSIBILITIES:

  • Apply knowledge of human factors principles (human performance and limitations – perceptual, cognitive, motor skills, anthropomorphic) and techniques (knowledge acquisition, user-interface design, usability evaluation) to cardiac electrophysiology systems product development
  • Organize and direct the work of staff and outside consultants working on human factors tasks to effectively and efficiently support product development efforts within the organization.
  • Deliverables include, but are not limited to: Usability engineering files; Task analyses; Usability risk analyses; Usability testing throughout the product development process, from formative testing of early prototypes through usability validation of final designs.
  • Develop collaborative working relationships with other functions across the organization, including but not limited to the following; Work with regulatory affairs to develop strategies for new product submissions, create submission packages, and respond to questions from regulatory agencies
  • Work with design quality to ensure that the company's usability engineering processes and methodologies meet and surpass the latest expectations of regulatory agencies and provide tangible value for our customers and our business.
  • Keep abreast of regulations and best practices for medical device human factors (e.g. IEC 62366, AAMI HE75, ISO 14971, and the latest FDA guidance on applying human factors engineering) and advice management regarding potential improvements to internal processes and regulatory issues related to human factors engineering
  • Represent in meetings with regulatory agencies, at human factors professional meetings and conferences, and as a member of standards committees.

POSITION REQUIREMENTS:

  • Proven ability to work with multidisciplinary teams that may include other human factors expert
  • Proven ability to interface with customers in a highly professional manner
  • Proven ability to apply user-centered design and human factors/usability engineering principles to product research, development and design
  • Experience in medical device development; ability to quickly assimilate advanced domain knowledge
  • Excellent verbal and written communication and presentation skills
  • Education: M.S. degree in Human Factors Engineering or Cognitive Psychology or M.S. degree in Biomedical Engineering with extensive human factors coursework
  • Years Experience: Minimum of 5 years of relevant human factors/usability engineering experience in hardware-software systems product development; prefer 10+ years experience


Posted: February 7, 2020, 12:43 pm
Category : Quality Engineer - Medical Device
Job Type : Contract
Id : 7841
Region : Twin Cities

Seeking a Quality Engineer II to consult with Manufacturing, Information Management, R&D, 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. 3-5 years experience desired.



Posted: February 7, 2020, 12:30 pm
Category : Manufacturing Engineer
Job Type : Contract
Id : 7840
Region : Twin Cities

Seeking a Quality Engineer II to evaluate, support, and troubleshoot a manufacturing line.

  • Evaluation of production equipment
  • Production support and process validation
  • Troubleshoot manufacturing process and equipment
  • Protocol and report writing
  • Generate and modify manufacturing process documentation
  • Work with cross functional teams as required
  • Develop and implement process improvements


Posted: February 3, 2020, 8:38 am
Category : Manufacturing Engineer
Job Type : Contract
Id : 7839
Region : Twin Cities

Seeking a Manufacturing Engineer to assist with the evaluation of production equipment and production support and process validation.

  • Troubleshoot manufacturing process and equipment
  • Protocol and report writing
  • Generate and modify manufacturing process documentation
  • Work with cross functional teams as required
  • Develop and implement process improvements



Posted: January 30, 2020, 2:23 pm
Category : Quality Engineering
Job Type : Contract
Id : 7838
Region : Twin Cities

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

Positon Responsibilities:

  • Establish processes based on product and print requirements.
  • Evaluate process and design alternatives based on Design for Manufacturability principles.
  • Production support - Responsible for providing technical support for processes and equipment to manufacturing to ensure high quality and yield
  • Process Optimization – Technical Reports and Test Method Validations
  • 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.
  • 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.
  • 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.)

Position Requirements:

  • Bachelor of Science in Engineering
  • 0-4 years engineering experience
  • Ability to work within a team and as an individual contributor in a fast-paced environment.
  • Ability to leverage and/or engage others to accomplish tasks.
  • Multitasks, prioritizes, and meets deadlines in a timely manner.
  • Strong verbal and written communication skills with ability to effectively communicate at multiple levels in the organization.
  • Strong organizational skills and attention to detail.
  • Ability to maintain regular and predictable attendance.
  • Experience developing manufacturing processes, technologies, and designing for manufacturability of medical devices.
  • Experience with statistical analysis (e.g. Gage R&R, Cpk, SPC, DOE), Minitab preferred.


Posted: January 30, 2020, 2:20 pm
Category : Quality Engineer - Medical Device
Job Type : Contract-to-Hire
Id : 7835
Region : Twin Cities

Seeking a Supplier Quality Engineer to initiate medical device quality assurance activities. 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: January 24, 2020, 7:23 am
Category : Manufacturing Engineer
Job Type : Contract
Id : 7833
Region : Twin Cities

The Associate Manufacturing Engineer designs manufacturing processes, procedures and production layouts for assemblies, equipment installation, processing, machining and material handling.

Position Responsibilities:

  • 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.

Required Knowledge and Experience:

  • Requires a University Degree
  • Entry Level position


Posted: January 22, 2020, 11:48 am
Category : R&D Engineer
Job Type : Contract
Id : 7830
Region : Twin Cities

Seeking a talented R&D Engineer, Human Factors Engineer to apply human factors and ergonomics expertise to the definition, design, and evaluation of products within the R&D division of Electrophysiology Systems, this is part of the Atrial Fibrillation business unit.

Position Responsibilities:

  • Apply knowledge of human factors principles (human performance and limitations – perceptual, cognitive, motor skills, anthropomorphic) and techniques (knowledge acquisition, user-interface design, usability evaluation) to cardiac electrophysiology systems product development.
  • Organize and direct the work of staff and outside consultants working on human factors tasks to effectively and efficiently support product development efforts within the organization.
  • Deliverables include, but are not limited to: Usability engineering files, Task analyses, and Usability risk analyses
  • Usability testing throughout the product development process, from formative testing of early prototypes through usability validation of final designs.
  • Develop collaborative working relationships with other functions across the organization, including but not limited to the following: Work with regulatory affairs to develop strategies for new product submissions, create submission packages, and respond to questions from regulatory agencies
  • Work with design quality to ensure that the company's usability engineering processes and methodologies meet and surpass the latest expectations of regulatory agencies and provide tangible value for our customers and our business.
  • Keep abreast of regulations and best practices for medical device human factors (e.g. IEC 62366, AAMI HE75, ISO 14971, and the latest FDA guidance on applying human factors engineering) and advice management regarding potential improvements to internal processes and regulatory issues related to human factors engineering.
  • Represent in meetings with regulatory agencies, at human factors professional meetings and conferences, and as a member of standards committees.

Position Requirements:

  • Proven ability to work with multidisciplinary teams that may include other human factors experts.
  • Proven ability to interface with customers in a highly professional manner.
  • Proven ability to apply user-centered design and human factors/usability engineering principles to product research, development and design.
  • Experience in medical device development.
  • Ability to quickly assimilate advanced domain knowledge.
  • Excellent verbal and written communication and presentation skills
  • Education: M.S. degree in Human Factors Engineering or Cognitive Psychology or M.S. degree in Biomedical Engineering with extensive human factors coursework.
  • Minimum of 5 years of relevant human factors/usability engineering experience in hardware-software systems product development; prefer 10+ years of experience


Posted: January 14, 2020, 1:58 pm
Category : Quality Engineer - Medical Device
Job Type : Contract
Id : 7826
Region : Twin Cities

The Senior 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.

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



Posted: January 13, 2020, 8:45 am
Category : Manufacturing Engineer
Job Type : Contract
Id : 7824
Region : Twin Cities

The Process Development 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. Requires a University Degree and minimum of 4 years of relevant experience.



Posted: January 10, 2020, 7:53 am
Category : Mechanical Designer
Job Type : Contract
Id : 7822
Region : Twin Cities

This Mechanical Design Engineer will provide computational modeling expertise in design and development of innovative products to treat Cardiac diseases. The emphasis will be on modeling mechanical systems to predict forces, deflections, stress, strain, and temperature within complex medical device assemblies subjected to in vivo and/or in vitro types of load conditions. Bearing in mind first principles, the engineer will understand customer requirements, formulate a modeling approach that will address those requirements, independently carry out the modeling activities and provide concise communication of the results through technical reports and presentations.

POSITION RESPONSIBILITIES:

  • The Engineer will apply advanced technical principles, theories, and concepts in working on complex technical problems and developing innovative solutions using computational models. The Engineer will use Finite Element Analysis (FEA) as the primary design and optimization tool for the development of innovative products.
  • Utilize FEA to assist in the design and evaluation of cardiac leads and devices
  • Apply modeling tools to help design and develop new test methods, and integrate new materials and processes
  • Work collaboratively with cross-functional product development teams to help bring products to market
  • Carry out timely troubleshooting by engaging peers, software technical support, and past experience
  • Perform model verification study and validation assessment as appropriate
  • Provide regular status updates to internal customers and management
  • Prepare reports and presentations to communicate technical assessments and analysis results
  • Provide technical input supporting submissions to regulatory bodies and governmental agencies
  • Provide peer feedback to others in the group on their work
  • Generate intellectual property and aid in the evaluation of intellectual property

BASIC QUALIFICATIONS:

  • BS degree in engineering with 3+ years of experience in non-linear finite element analysis
  • Proven expertise in structural mechanics and mechanics of materials
  • Demonstrated problem solving and critical thinking skills
  • Demonstrated verbal and written communication skills
  • Demonstrated time management and organization skills
  • Demonstrated ability to build relationships and work effectively with others on cross-functional teams

DESIRED/PREFERRED QUALIFICATIONS:

  • PhD degree in engineering (Mechanical, Materials, Biomechanical, or Biomedical)
  • 6+ years of experience in non-linear finite element analysis
  • Experience using FEA/CFD for device design, optimization, testing verification, method validation, and regulatory submissions
  • Experience in solving multiphysics problems that requires coupling among mechanical, thermal, electromagnetics and fluid behaviors
  • Experience in modeling of manufacturing processes such as metal forming, injection molding, welding and plastic joining
  • Experience in working methods for low and high-cycle fatigue
  • Experience with Six Sigma practices and statistical methods
  • Experience with CAD software such as Pro/Engineer or Solidworks
  • Experience with Abaqus CAE (Explicit/Standard), or LS-DYNA
  • Experience with ANSYS Fluent, Icepak
  • Experience with Mimics or Simpleware
  • Experience with CAD software such as Pro/Engineer or Solidworks
  • Experience with programming/scripting in Python and Matlab



Posted: January 8, 2020, 7:15 am
Category : BioMedical Engineer
Job Type : Contract
Id : 7821
Region : Twin Cities

This Senior Biomedical Engineer will provide computational and electrophysiological modeling expertise in design and development of innovative products for cardiac stimulation therapies diseases. The engineer will understand business requirements, formulate a modeling approach that will address those requirements, independently carry out the modeling activities and provide concise communication of the results through technical reports and presentations.

 

POSITION RESPONSIBILITIES:

  • Perform theoretical and finite element analysis (FEA) to predict cardiac system behavior under in vivo and/or in vitro use conditions. This individual will develop technical solutions to complex problems that require the regular use of creativity and critical thinking.
  • Utilize FEA and other numerical techniques to develop electrophysiological cardiac models capable of capturing physiological effects (e.g. coupled excitation contraction) and able to incorporate cardiac devices to assist in the design and evaluation of cardiac devices.
  • Develop computational electrophysiology models for cardiac stimulation therapies
  • Work collaboratively with cross-functional product development teams to help bring products to market
  • Carry out timely troubleshooting by engaging peers, software technical support, and past experience
  • Perform model verification study and validation assessment as appropriate
  • Provide regular status updates to internal customers and management
  • Prepare reports and presentations to communicate technical assessments and analysis results
  • Generate intellectual property and aid in the evaluation of intellectual property

 

MINIMUM QUALIFICATIONS:

  • Bachelor engineering degree with demonstrated experience in computational modeling, e.g. FEA/CFD
  • Demonstrated knowledge or expertise in cardiovascular physiology
  • Experience in solving multiphysics problems that requires coupling among mechanical, electrical, biological and fluid behaviors
  • Experience with incorporating subject- and/or patient-specific features into computational modelling methods
  • Demonstrated verbal and written communication skills
  • Experience with programming/scripting in Python and Matlab
  • Experience with Abaqus CAE (Explicit/Standard), or LS-DYNA
  • Experience with Mimics or Simpleware

 

DESIRED/PREFERRED QUALIFICATIONS:

  • PhD degree in fields of cardiovascular physiology, medical device, or mechanical engineering
  • Ability to scope tasks and projects (time, resources and tools) to develop a schedule and update management.
  • Ability to build relationships and work effectively with others on cross-functional teams
  • Experience with ANSYS Fluent, Icepak
  • Experience with CAD software such as Pro/Engineer or Solidworks
  • Demonstrated problem solving and critical thinking skills
  • Demonstrated time management and organization skills
  • Demonstrated ability to learn and apply new knowledge quickly


Posted: January 8, 2020, 6:57 am
Category : Mechanical Engineer
Job Type : Contract
Id : 7817
Region : Twin Cities

The Human Factors Design Engineer applies human performance principles, methodologies, and technologies to the design of humanmachine systems and products. Develops and implements research methodologies and statistical analysis plans to test and evaluate developmental prototypes used in all phases of products development and processes. Designs and executes tests to simulate product use for the purposes of concept selection/refinement, requirements development, use related risk identification and formal usability validation with intended users. Interfaces with design engineers to establish system design, operating, and training requirements and to ensure optimized humanmachine interfaces. Identifies and analyzes technological problems or risks, performs theoretical human factors investigations, and develops and implements research and analysis plans. 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. Requires a University Degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.



Posted: December 18, 2019, 1:03 pm
Category : Systems Engineer
Job Type : Permanent
Id : 7806
Region : Twin Cities

Seeking a Principal Systems Engineer to technically lead engineering teams through innovative design, development and deployment of the company’s medical device products that meet customer specifications and quality standards. This position will also ensure alignment of product development strategy to business strategy in order to accelerate the development and commercialization of products to the market. As a member of the broader organizations technical leadership team, promote and drive innovation and excellence through cross-functional collaboration and decision making while representing product development engineering interests.

Primary Duties and Responsibilities:

  • Understand the project/customer requirements and drive system and functional architectural decisions
  • Take technical ownership of entire system from inception to product delivery including (Electrical, Firmware, Software and Mechanical) architectural decisions
  • Drive system requirements, system specifications, input/output processes and working parameters by using systems engineering best practices
  • Drive system partitioning (i.e. hardware/software partitioning) and coordinate total system integration.
  • Solve system problems through simulation, mathematical analysis, and/or systems interaction testing/analysis.
  • Lead integration of product technologies with respect to mechanical, electrical, firmware and software for multiple on-going projects
  • Facilitate cross-functional technical decision making with ultimate ownership within the team
  • Key stakeholder in the technical development strategy for the project
  • Internal and external stakeholder communication on key technical updates and issues
  • Work with internal/external partners as necessary to leverage key capabilities as needed for the project
  • Interface directly with leadership team on project status/issues
  • Mentor engineers in engineering activities/methodologies and domain knowledge
  • Coordinate system testing including evaluation, validation & verification activities.
  • Drive systems engineering center of excellence as key discipline across the organization.
  • Execute risk management/mitigation activities and system issue resolution for the project.

Minimum Qualifications:

  • Bachelors’ degree in Engineering, preferably systems, electrical, mechanical, or software
  • 10+ years of engineering experience
  • 3-5+ years new product development in a systems engineering role
  • Demonstrated experience with risk management and systems engineering processes
  • Ability to grow productive, trusting and open relationships with a wide variety of constituencies and communicate across the organization
  • Effective verbal and written communication skills
  • High degree of organizational skills and high attention to detail
  • Ability to clearly and accurately translate needs and requirements
  • Ability to handle multiple tasks and prioritize effectively
  • Ability to work both independently and as part of a team
  • Ability to develop protocols, conduct system tests and write reports

Preferred Qualifications:

  • Systems Engineering degree(s)
  • 10+ years systems engineering experience
  • Voice-of-customer experience
  • Technology research experience
  • Strong cross-functional knowledge (electrical, mechanical, software, regulatory, etc.)
  • Experienced in the design of experiments, data analysis, statistical methods and presentation of results
  • Familiarity with functional database and software tools for managing projects, requirements, risk, etc.


Posted: December 3, 2019, 2:37 pm
Category : Product Manager
Job Type : Permanent
Id : 7802
Region : Twin Cities

Seeking a Product Manager to be responsible for guiding the success of our electric actuator and motion control products and organizing the cross-functional team that is responsible for improving it. This important organizational role sets the strategy, roadmap, and feature definition for a product or product line. This role also sets pricing, analyzes profitability, works on forecasting, does market research and is a sales champion for the products in the field.

Qualifications:

  • Bachelor’s degree in engineering, or a related physical science field (Mechanical engineering preferred).
  • At least 4 years of experience in a related industrial product management, marketing and/or outside sales capacity and/or applications engineering, preferably in the automation or motion control industry.
  • Demonstrated ability to develop and maintain effective product management strategies for the life cycle of a technical product.
  • Strong presentation skills with the ability to present technically to a broad audience.
  • Ability to strategically analyze data, consult with stakeholders, formulate a position and then present a compelling argument for that position.
  • Demonstrated ability to manage a project from concept through fulfillment.
  • Technically competent to effectively manage all programs associated with assigned products.
  • Sound decision-making abilities; ability to work both independently and in a team environment.
  • Ability to travel 20-25% of the time.
  • Ability to communicate effectively, both verbally and in writing, with a wide audience on technical subjects.


Posted: November 25, 2019, 2:29 pm
Category : Software Engineer
Job Type : Contract-to-Hire
Id : 7788
Region : Twin Cities

The Principal Software Architect works with the Software Engineering team and has the prime responsibility of leading the company’s team of Software Engineers, including the formation of software architecture and development plans on projects requiring software/firmware.

Requirements:

  • A Bachelor’s degree in Computer Science/Engineering, coupled with 10+ years of experience in systems software development within the medical device arena is required along with the following key attributes:
  • Skilled in the art of software systems architecture for both embedded software and larger interconnected software systems
  • Experience leading software teams in a multi-disciplined environment
  • Ability to translate user needs and system design specifications and into software requirements
  • Experience designing and developing software and firmware applications in response to functional specifications
  • Experience using industry standard tools and practices to document and visualize software system architecture
  • Experience designing and developing embedded applications with intensive, interrupt driven communications for real-time process control applications using multiple serial channels and communications protocols (proprietary and standard based)
  • Experience in developing cloud software systems and mobile application software
  • Experience in developing wireless applications and devices
  • Experience in sensor and instrumentation integration
  • Experience creating software development plans and schedules
  • Extensive use of debugging tools, including software debuggers and basic use of electronic diagnostic devices for software development, integration, debugging, and troubleshooting
  • Integrate firmware with a variety of hardware platforms and to analyze and troubleshoot the hardware/firmware interface
  • Prefer Certified Cloud Solutions Architect (AWS or Azure)
  • Experience with ISO 13485, IEC 62304, FDA design controls or similar regulatory environment

Our fast-paced environment demands the ability to manage multiple projects within various disciplines and deadlines. High-energy, self-starters with the following qualities:

  • Successful communication skills, business acumen and assertive decision-making ability
  • Flexibility to multi-task and perform a wide range of activities
  • Excellent computer skills, including MS Office proficiency

Responsibilities:

  • Work with the greater development team, including Systems Engineering, to develop high level software requirements
  • Design, develop and document software systems architecture for projects ranging from small embedded systems to larger interconnected systems.
  • Support the software development team with translating high level software requirements into detailed software requirements, supporting the documented software architecture
  • Verify that the documented architecture is implemented according to plan through participation in code reviews and design reviews throughout the process
  • Dictate design choices to software developers, including, but not limited to: platforms, coding, and technical levels
  • Create project software development plans, which may favor either a waterfall or agile development process.
  • Work with the program management team on creating accurate software project schedules
  • Maintain and continually improve the software architecture and development process, as technologies and teams evolve
  • Design and develop firmware for embedded systems. Integrate developed applications with other components
  • Mentor junior staff and serve as software onboarding liaison for new employees
  • Assist hardware engineers in development of new platforms and in troubleshooting hardware/software interfaces
  • Document and perform integration, testing, debugging and installation support and activities
  • Participate with project team in the design and implementation of new and enhanced products
  • Develop control algorithms to optimize module and display system performance
  • Interface with design team to support functional test and measurement requirements
  • Initiate and maintain FDA software design control documents
  • Support the manufacturing process by designing and developing production automation software


Posted: November 11, 2019, 8:51 am
Category : Product Manager
Job Type : Permanent
Id : 7785
Region : Twin Cities

Seeking a high caliber Engineering Project Manager who will be responsible for achieving successful execution of various product development initiatives in support of the company's strategy.  The Project Manager serves as a cross-functional team lead with responsibility for defining, developing and delivering new products for our customers while ensuring team commitments are met and communicated in a timely fashion.  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:

  • Create and maintain multiple project development schedules
  • Monitor and track progress toward project objectives, manage project schedules and budgets, and implement strategies to ensure successful delivery of the project on time and on budget
  • Use broad cross-functional knowledge to provide direction to a cross-functional product development team
  • Provide leadership to ensure overall quality of multiple projects, while minimizing project risks
  • Ensure alignment and communication between groups including Engineering, Operations, Marketing, Clinical, and Quality
  • Perform other related duties and responsibilities, on occasion, as assigned.

 

Qualifications:

  • Exceptional project management skill; knowledge of process and project planning best practices
  • Demonstrated capacity for strategic thinking, project planning and management
  • Excellent communication skills and interpersonal/team effectiveness with an ability to accurately communicate to engineering team and management
  • Clear understanding of the roles and responsibilities of cross-functional project teams
  • Ability to negotiate and manage competing priorities across multiple functional areas
  • Knowledge of FDA, GMP, and ISO 13485; any experience with QSR implementation is desired, but not required.
  • Demonstrated ability to effectively and clearly communicate concepts, ideas and knowledge to other individuals and teams.
  • Advanced computer skills and working knowledge of Microsoft Office applications.

 



Posted: November 11, 2019, 7:59 am
Category : Mechanical Designer
Job Type : Contract
Id : 7778
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: November 5, 2019, 12:50 pm
Category : Technicians
Job Type : Contract-to-Hire
Id : 7776
Region : Twin Cities

Seeking a Production Technician to support 3D or 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 : Firmware Engineer
Job Type : Permanent
Id : 7766
Region : Twin Cities

We are currently hiring an Embedded Linux Software Engineer to develop embedded software for new products and maintain existing product lines through improvement updates. Preference is someone experienced working with open source tools as well as traditional embedded software technologies used in a regulated environment for medical devices.

Responsibilities:

  • Development of C/C++/C++ v11 embedded software applications for both new and existing medical devices
  • Adapt and extend existing embedded Linux applications to add new features to current products, analyze the existing architecture and if applicable, adjust and extend it to allow reuse across additional future products.
  • May coach and develop entry level engineers by sharing knowledge and best practices
  • Assist in planning, estimating, and scheduling software development efforts
  • Review, and guide technical work and issue resolution providing multiple options and ensuring that all work meets requirements and specifications in compliance with the quality system and best practices
  • Maintain frequent communication within and outside of the department in support of engineering activities and project plans
  • Assure appropriate documentation for assigned project
  • Understands and follows requirements of SOPs.
  • Contribute to corrective action development and alternatives.
  • Determine resolution of intermediate technical issues as needed and assures that technical work meets specified requirements.
  • Conducts testing for assigned projects.
  • Prepare documentation associated with engineering activities.
  • Conduct design testing.
  • Operate with a significant amount of latitude and freedom. Within these minimal constraints, may lead medium to large projects; plans and authorizes tests and approves test evaluations; directs and approves documentation and related drawings; designs components, parts or systems of significant difficulty; oversees/approves troubleshooting resolutions.
  • Perform engineering work requiring full competency in all conventional aspect of engineering
  • Plans and conducts work requiring judgment in the independent evaluation, selection and the substantial adaption of standard engineering techniques, procedures and requirements. Plans and coordinates detailed phases of engineering actions for part of a project
  • Performs assignments independently troubleshooting tasks as related to product problems.
  • Performs assignments independently with limited supervision as to expected results.
  • Independently plans, schedules, conducts or coordinates detailed phases of the assigned project.
  • Continuously reviews project team progress and evaluates results accordingly.
  • Works under only general supervision, with direction given only in terms of broadly stated objectives and desired outcomes.

Requirements:

  • Minimum Bachelor's degree in engineering or similar. Software or Electrical Engineering preferred
  • 3-5 years of experience or 2-5 years with an advanced degree.
  • 3+ years of Embedded Linux experience (Buildroot or similar)
  • Experience writing C and C++ applications running on Linux, RTOS, bare metal, uCOS, or similar
  • Experience working with UI frameworks such as Qt, Altia or similar
  • Able to write clean, safe, readable code
  • Applies extensive technical expertise in the engineering field and has knowledge of other related disciplines (Global Product Management, Quality, Regulatory, Sales and Operations)
  • Work under only general supervision from the Engineering Manager, with direction given only in terms of broadly stated objectives and desired outcomes
  • Ability to clearly convey ideas and concepts verbally and in writing

Preferred Requirements:

  • Experience in regulated product development environments preferred
  • Experience in multiple areas of an embedded device (UI, communications, databases, drivers, OS) through all stages of the development process, including for example, requirements, architecture design, coding, test, documentation, and safety analysis highly preferred
  • Experience developing and debugging complex software systems highly preferred
  • Experience planning, scheduling, and conducting multiple phases of a software project highly preferred
  • Experience working in an Agile development environment using tools such as Git, Jira, TFS, etc.
  • Experience in python and bash scripting and creating automated test frameworks preferred
  • Experience coaching and mentoring others in technical matters and related project initiatives preferred
  • Strong influencing skills and ability to convey clear supporting evidence for proposals
  • Ability and willingness to lead and create changes in policy, procedure, technology, and culture


Posted: October 16, 2019, 7:24 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 : Quality/Regulatory
Job Type : Contract
Id : 7756
Region : Twin Cities

Seeking a detail-oriented, proactive Certification Project Manager to run numerous certification projects.  Project coordination entails being main point of contact for customer, arranging certifications with test labs,

 

Position Description:

  • Work with test labs and other certification experts to determine what is needed to be able to certify current Company products for sale in counties outside of North America and Europe
  • Gather certification quotes from test labs and estimate support labor for potential certification projects.
  • Writing statement-of-work documents, which function as project proposals
  • Consult with internal Company employees to find test reports, product information, and any other information or help needed to complete new country certifications for existing Company products
  • 30+ hours per week
  • Certification/regulatory experience required

 

Posted: September 26, 2019, 1:24 pm
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 : 7724
Region : Twin Cities

Seeking a Senior Mechanical Design Engineer for the following duties:

  • Develop mechanical automation designs from customer specifications
  • Provide technical direction in a team-oriented work environment
  • Lead all design aspects for assigned projects in a team-oriented work environment
  • Develop and implement design standards
  • Perform or participate in internal project design reviews
  • Interface with customers on technical projects
  • Use analytical tools to assist in the design process
  • Interface with suppliers

 

Skills/Qualifications:

  • Experience with 3D CAD modeling packages - Solidworks and Unigraphics a plus
  • Ability to manage an automation design from the concept phase through modeling and detailing
  • Experience in a "systems" approach to automation design
  • Demonstrated ability to own and drive projects to completion
  • The drive to consistently deliver on commitments

 

Position Requirements:

  • BS or MS in Mechanical Engineering
  • 4 – 6 years of experience in automated design
  • Only those persons authorized to work permanently for any employer in the US will be considered


Posted: August 28, 2019, 12:44 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.

 

Essential Duties and Responsibilities

  • Applies principles of mechanics, thermodynamics, hydraulics, heat transfer, and materials.
  • Designs medical products and confirms correctness using methodologies and tools such as FEA, GD&T, CFD, etc.
  • Evaluates mechanical and electromechanical systems and products by designing and conducting research programs.
  • Leads and completes medical standard document deliverables.
  • Identifies and efficiently resolves technical problems and issues.
  • 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.
  • Prepares product reports by collecting, analyzing, and summarizing information and trends.
  • Delegates and sets work direction for technicians and designers.
  • Works with suppliers and manufacturing facilities to design for manufacturability.

 

Education/Experience:

  • Bachelor's degree in Mechanical Engineering or equivalent
  • Minimum 3+ years of experience in new product development.
  • Direct experience with the product development process ranging from requirements development, prototyping, verification and product release is required.
  • Experience in medical device design or other regulated industries preferred.
  • Must have demonstrated experience working on electromechanical systems.
  • Prefer experience with IEC 60601-1 and with ISO 14971 Risk Management for Medical Devices.
  • Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. 
  • Ability to write reports, business correspondence, and procedure manuals.
  • Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the public.

 



Posted: May 14, 2019, 11:46 am
Category : Test Engr - Technical
Job Type : Permanent
Id : 7626
Region : Twin Cities

Seeking a Senior Software Test Engineer 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 software test system requirements
  • Design 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
  • Ability to design TestStand or 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: April 4, 2019, 12:07 pm
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 : Software Engineer
Job Type : Contract
Id : 7548
Region : Twin Cities

 

Essential Job Functions & Responsibilities:

  • Embedded firmware design and implementation
  • Support projects for new and existing customers. This will require theoretical analysis, simulation analysis, software/firmware implementation, code review, documentation, and hardware/software integration testing.
  • Support communication protocol development efforts: network security protocols, wireless mesh networking and network security
  • Support development in multiple operating systems:  Linux, FreeRTOS, bare metal, Windows, etc.
  • Coordinate and work collaboratively cross functionally as well as with other software development teams in the organization
  • Lead software efforts being self-directed as well as leading small software teams
  • Mentor junior engineers in current trends and best practices
  • Provide outstanding documentation of software designs
  • Assist with certification testing
  • Coordinate software releases with internal and external stakeholders
  • Participate in appropriate training and development programs to maintain and enhance job-related skills

 

Required Qualifications:

  • Minimum: BS or MS in Computer Engineering, Electrical Engineering or Computer Science
  • 10+ years of related experience
  • Direct experience in programming in C for real-time embedded systems
  • Significant experience working with 32-bit microcontrollers in a flash and RAM constrained system
  • Significant experience with microcontroller peripherals and interfaces: UART, SPI, ADC, PWM, Timers, etc.
  • Development experience with embedded Linux (layers below application) and RTOS/bare metal
  • Skilled in the use of test and debug equipment: oscilloscopes, logic analyzers, multi-meters, spectrum analyzers, etc.
  • Demonstrated ability to function self-directed in leading software engineering efforts
  • Demonstrated ability to lead a small team of software engineers, i.e. task planning/managing, mentoring, defining core architecture, etc.
  • Good communication and team skills, both externally and internally
  • Solid debugging, troubleshooting, and problem solving ability
  • Eagerness to collaborate with team members and coworkers within the organization
  • Solid experience in delivering quality documentation (Requirements, Design Doc's, test plans)
  • Experience working through all phases of software development (Concept, architecture, development, test, release to manufacturing)

 

Preferred Qualifications:

  • Experience in developing Linux Kernel drivers, and low level Linux protocols
  • Experience in developing in real-time operating systems
  • Experience with RF communication
  • Experience with RF protocols at the PHY/MAC/NWK layers such as 802.15.4, zigbee, BLE, or Wi-Fi
  • Experience with networking protocols
  • Experience with a revision control system, GIT is preferred
  • Python experience
  • Experience with unit testing


Posted: November 20, 2018, 11:57 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
Category : Technician - Medical Equipment
Job Type : Contract
Id : 7319
Region : Twin Cities

Immediate opportunity for an Equipment / Controls Automation Technician to support design, start-up, troubleshooting, and validation of automated equipment for medical device product manufacturing. This position will support Controls Engineers in machine design development, including Autocad Electrical design and documentation of control panels, schematics, and mechanical components, updating / programming PLC and HMI software, support repeat equipment builds, and troubleshooting and solving hardware and software (PLC, HMI, Vision) issues.

Requirements include:

  • 2 year Electrical / Automation Tech degree, with
  • Training and experience in design, programming, and troubleshooting of industrial control systems.
  • Requires proficiency with Autocad Electrical Cad, and training in troubleshooting PLC and HMI systems, robotics, machine vision, and controls instrumentation.
  • Will consider entry level candidate with solid training in automated systems, or technician with up to several years of experience.


Posted: April 2, 2018, 8:52 am
Category : Controls Engineer
Job Type : Contract
Id : 7297
Region : Twin Cities

 

Seeking a Machine Vision Software Engineer / Electrical Engineer / Software Engineer needed 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.

 

Requirements:

  • Bachelor of Science (CS or EE)
  • Manager is open to all levels of experience with automated equipment development, including some hands-on vision system knowledge.
  • Prefer experience with .NET and C++ programming, Allen Bradley PLC's and understanding of automated equipment design.
  • Prefer experience with 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 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 and hardware 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: March 15, 2018, 12:25 pm