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Development Resource Group

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Category : Packaging Engineer
Job Type : Contract
Id : 8412
Region : Twin Cities

The Sr. Packaging Engineer designs, develops, and tests a wide variety of containers used for the protection, display, and handling of products. Determines packaging specifications according to the nature of the product, cost limitations, legal requirements, and the type of protection required, considering need for resistance to such external variables as moisture, corrosive chemicals, temperature variations, light, heat, rough handling, and tampering. Designs package exteriors considering such factors as product identification, sales appeal, aesthetic quality, printing and production techniques. Responsibilities may include documentation management and/or coordination of Good Manufacturing Practices (GMPs), and may support prototype line development in manufacturing facilities/plants.Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University).Autonomy: Seasoned individual contributor. Works independently under limited supervision to determine and develop approach to solutions. Coaches and reviews the work of lower level specialists; may manage projects / processes.Organizational Impact: May be responsible for entire projects or processes within job area. Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments.Innovation and Complexity: Problems and issues faced are difficult, and may require understanding of multiple issues, job areas or specialties. Makes improvements of processes, systems or products to enhance performance of the job area. Analysis provided is in-depth in nature and often provides recommendations on process improvements.Communication and Influence: Communicates with senior internal and external customers and vendors. Exchange information of facts, statuses, ideas and issues to achieve objective, and influence decision making.Leadership and Talent Management: May provide guidance, coaching and training to other employees within job area. May manage projects, requiring delegation of work and review of others' work product.Required Knowledge and Experience: Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience. May have practical knowledge of project management. Requires a University Degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.

Posted: July 30, 2021, 11:22 am
Category : Firmware Test
Job Type : Contract
Id : 8409
Region : Twin Cities

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



Posted: July 27, 2021, 1:26 pm
Category : Technical Writer
Job Type : Contract
Id : 8408
Region : Twin Cities

Seeking a Technical Writer to plan, research, develop, and write medical device labeling, and manage labeling deliverables as part of cross-functional project teams under general supervision.

  • Understand and adhere to all quality management system documents and product commercialization procedures applicable to labeling development.
  • Research and write requirements used to create labeling content, and write requirement trace reports.
  • Oversee Engineering Change Order process for labeling.
  • Complete labeling proofs, develop documentation for regulatory submissions, and carry out other tasks as assigned.
  • Requires a University Degree and minimum of 2 years of relevant experience, or advanced degree with 0 years of experience.
  • Experience with EU MDR desired.


Posted: July 27, 2021, 8:36 am
Category : Mechanical Engineer
Job Type : Contract
Id : 8407
Region : Twin Cities

The Sr. Human Factors Design Engineer applies human performance principles, methodologies, and technologies to the design of human machine 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 human machine interfaces. Identifies and analyzes technological problems or risks, performs theoretical human factors investigations, and develops and implements research and analysis plans.

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. The 3 most important skill sets/experiences are: -Experience as a Human Factors Engineer -Experience in the Medical Device or other highly regulated industry -Knowledge of global regulatory expectations for Human Factors



Posted: July 23, 2021, 11:49 am
Category : Mechanical Engineer
Job Type : Contract
Id : 8406
Region : Twin Cities

Seeking an experienced Process Engineer to help with Project planning and Process mapping on an upcoming development project and support process development deliverables for a high priority ongoing development project for a major medical device company. Looking for an Engineer with prior upstream project planning experience preferred. Also prior process development and/or equipment development and characterization experience preferred to make up lost ground on initial installations, configuration and setup, IQ inputs (TIRs, Cals, PMs, etc) and other needs as they arise for the ongoing development project. Ideal candidate will have some relevant process engineering background, highly motivated and driven and has the potential to work under minimal direction. The candidate should be a good team player, proactive, strong execution of deliverables, timely escalations as needed and good team communication

Bachelors degree in a related field and 2-5 years experience required.



Posted: July 23, 2021, 8:25 am
Category : Reliability Engineer
Job Type : Contract
Id : 8405
Region : Twin Cities

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

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

Autonomy: Seasoned individual contributor. Works independently under limited supervision to determine and develop approach to solutions. Coaches and reviews the work of lower level specialists; may manage projects / processes.

Organizational Impact: May be responsible for entire projects or processes within job area. Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments.

Innovation and Complexity: Problems and issues faced are difficult, and may require understanding of multiple issues, job areas or specialties. Makes improvements of processes, systems or products to enhance performance of the job area. Analysis provided is in-depth in nature and often provides recommendations on process improvements.

Communication and Influence: Communicates with senior internal and external customers and vendors. Exchange information of facts, statuses, ideas and issues to achieve objective, and influence decision making.

Leadership and Talent Management: May provide guidance, coaching and training to other employees within job area. May manage projects, requiring delegation of work and review of others' work product.

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



Posted: July 22, 2021, 1:31 pm
Category : Reliability Engineer
Job Type : Contract
Id : 8404
Region : Twin Cities

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

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

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

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

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

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

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



Posted: July 22, 2021, 1:23 pm
Category : Electrical Engineer
Job Type : Contract
Id : 8403
Region : Twin Cities

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

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

Autonomy: 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 a bachelor of science in Electrical Engineering and at least 5 years of EE analog design



Posted: July 22, 2021, 10:08 am
Category : Project Leader
Job Type : Contract
Id : 8402
Region : Twin Cities

The Project Analyst oversees and manages the operational aspects of ongoing projects 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 new or existing products. Reviews status of projects and budgets; manages schedules and prepares status reports. Monitors the project from initiation through delivery. Assesses project issues and develops resolutions 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.

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. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University).

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

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

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

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

Leadership and Talent Management: May provide guidance and assistance to entry level professionals and / or employee in Support Career Stream. Required Knowledge and Experience: Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience. Requires a University Degree and minimum of 2 years of relevant experience, or advanced degree with 0 years of experience.



Posted: July 21, 2021, 10:03 am
Category : Quality/Regulatory
Job Type : Contract
Id : 8401
Region : Twin Cities

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

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

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

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

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

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

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

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



Posted: July 21, 2021, 6:42 am
Category : R&D Engineer
Job Type : Contract
Id : 8399
Region : Twin Cities

Working under general supervision, the R&D Engineer will support product development efforts by performing clinical-systems and human factors engineering tasks such as investigating, defining, analyzing, documenting and testing activities associated with the development of specific projects.

Perform additional analysis and/or interviews to determine the requirements and constraints on the assigned portion of the system.

The position requires the application of theoretical principles, evaluation, ingenuity and creative/analytical techniques typically acquired in a recognized four-year or more academic course of study.

Must have the ability to apply technical, clinical and marketing understanding of issues to bring tasks to resolution within assigned projects.

Will apply engineering and scientific principles to the evaluation and solution of technical problems.

Will exercise appropriate level of technical judgment in planning, organizing, performing and coordinating clinical-systems engineering assignments.

Will routinely uses the most effective, cost efficient and best practices to execute processes.



Posted: July 15, 2021, 8:44 am
Category : Reliability Engineer
Job Type : Contract
Id : 8398
Region : Twin Cities

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

Position Requirements/Qualifications:

  • Bachelor of Science in Engineering or relevant field
  • At least 2-5 years relevant experience
  • Experience in Manufacturing, Manufacturing Quality Assurance, or Mechanical Engineering
  • Experience in a highly regulated industry, preferably implantable medical devices
  • Reliability engineering experience, including product performance modeling and trending
  • Demonstrated ability to perform data analysis using statistical techniques and reliability tools.
  • Demonstrated critical thinking skills with focus on improved system performance outcomes and positive business impact
  • Influential, accurate, and decisive written and oral communication skills


Posted: July 13, 2021, 7:38 am
Category : Manufacturing Engineer
Job Type : Contract
Id : 8397
Region : Twin Cities

Seeking a Manufacturing Engineer to 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 for a major medical device company. This position will set direction for, lead, and take ownership of complex manufacturing engineering technical tasks that 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.

Bachelor Science or Bachelor Engineering, Electrical, Software, or Mechanical Engineering is required with a minimum 2-5 years of experience in an engineering discipline.



Posted: July 12, 2021, 8:27 am
Category : Mechanical Engineer
Job Type : Contract-to-Hire
Id : 8393
Region : Twin Cities

Seeking a Mechanical Project Engineer to be a steward for the environment by developing low-power LED products and reducing energy consumption while delivering lighting products that enhance businesses or homes.

Responsibilities:

  • Design new products and develop improvements for current products.
  • Create and maintain costed BOMs and drawings for new and existing products.
  • Create manufacturing drawings and work instructions.
  • Keeping engineering documentation up to date and organized
  • UL-Approvals, Regulatory Certifications
  • Repairing equipment
  • Investigating production problems
  • Making improvements to current operations to enhance efficiency.
  • Production support
  • Technical interface for customers and suppliers
  • New equipment implementations
  • Product testing and documentation
  • Project management
  • Follow Quality Management System policies and procedures.

Qualifications:

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


Posted: July 9, 2021, 7:40 am
Category : Reliability Engineer
Job Type : Contract
Id : 8394
Region : Twin Cities

Seeking a Reliability Engineer to support the planning, execution, documentation, and approval of test method validation and design verification studies. This position will create and modify risk analysis documentation to support design of new processes and products; ensure compliance with relevant safety regulations, QSRs, ISO Standards, EU MDR, MDD, Quality Business System and Key Corporate Policies; review and approve changes to designs/processes and assess impact on product and qualification status, and be responsible for providing input for Regulatory submissions

POSITION REQUIREMENTS:

  • Medical device experience
  • Risk management experience
  • Test method development and validation/Software Quality assurance experience
  • Education Required: BS biomedical engineer, BS mechanical engineering or BS electrical engineering
  • Years’ Experience Required: 3-5 years


Posted: July 9, 2021, 7:35 am
Category : Test Engr - Technical
Job Type : Permanent
Id : 8392
Region : Twin Cities

Looking for a talented Sr. Test System Engineer for end to end development of electrical and/or software solutions for custom functional test systems including, writing test requirements; test system development and integration; acceptance testing and technical support. Primary responsibilities are test hardware and software design. Successful candidates can expect a wide variety of test design and integration projects.

Major Areas of Accountability:

  • Develop test system requirements
  • Design hardware/software solutions that satisfy test system requirements with emphasis on hardware design.
  • 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.
  • 8 years of related test engineering experience required; 10 years preferred.
  • Automated functional test development experience desirable.

Knowledge, Skills, and Abilities:

  • Ability to select test hardware base on a test specification.
  • Knowledge of Visio and Altium PCB designer a plus.
  • Application software development skills in Microsoft Visual Studio (VB.NET/C#). C/C++ experience a plus.
  • NI LabVIEW/Test Stand program development skills a plus.
  • Analyze existing test solution (electrical/software) and understand the design for maintenance or updating/upgrading.
  • 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
  • This position may require working additional hours during periods of peak demand
  • Maintains confidentiality and security of intellectual property (ITAR, Prototype)


Posted: July 8, 2021, 8:23 am
Category : Mechanical Engineer
Job Type : Contract
Id : 8391
Region : Twin Cities

Seeking a Sr. Mechanical Design Engineer to research, plan, design, verify, validate and develop mechanical and/or electromechanical products and systems, such as metals, instruments, controls, plastics, robots, engines, machines and mechanical, resonance, hydraulic or heat transfer systems for production, transmission, measurement, and use of energy. Recommends various technology options or approaches for system, processes, facility or program improvements in terms of safety, performance, efficiency or costs.  May be responsible for the transfer from R&D to manufacturing.

 

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



Posted: July 2, 2021, 8:09 am
Category : Manufacturing Engineer
Job Type : Contract
Id : 8388
Region : Twin Cities

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



Posted: July 1, 2021, 1:21 pm
Category : Test Engr - Technical
Job Type : Contract
Id : 8385
Region : Twin Cities

The Test Engineer designs, develops, and implements product security testing methods. Plans, arranges, and executes penetration testing on medical devices. Compiles testing data and defines recommendations for how to make products more secure.

Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers projects assigned and works with other stakeholders to achieve desired results. The majority of time is spent delivering the projects from design of testing steps to execution of those tests and documenting results. This includes explaining technical testing results to non-technical team members.

  • Autonomy: Established and productive individual contributor. Works independently with general supervision on larger, moderately complex projects / assignments. 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 . Recommends enhancements in systems and processes to solve security problems.
  • 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.
  • Required Knowledge and Experience: Requires practical knowledge and demonstrated competence within security typically obtained through advanced education combined with experience. Requires a University Degree and minimum of 2 years of relevant experience.

Other tasks include:

  • Employ a variety of test methods to perform comprehensive vulnerability assessment and penetration testing of products
  • Leverage “attacker like” testing techniques against products
  • Document and communicate the results of testing to relevant stakeholders
  • Coordinate with Development and Product Support teams
  • Leverage existing tools a develop a more robust Security Testing Program
  • Maintain awareness of existing and emerging medical device security research and leverage that knowledge during internal testing activities
  • Understand current FDA policies surrounding cybersecurity and utilize that knowledge to inform testing activities.
  • Identify opportunities for product security enhancement
  • Show creativity and innovation in all aspects of your responsibilities
  • Own your own training and development to ensure skills are in line with project needs
  • Participate on ad hoc Product Security Office Projects, as needed


Posted: June 30, 2021, 1:57 pm
Category : Systems Engineer
Job Type : Contract
Id : 8383
Region : Twin Cities

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

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

  • Autonomy: 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: June 30, 2021, 6:26 am
Category : R&D Engineer
Job Type : Contract
Id : 8382
Region : Twin Cities

The R&D Engineer designs, develops, analyzes, troubleshoots and provides technical skills during research and/or product development. Designs studies to investigate specific life science questions within field of expertise. May be involved in product research and development and/or clinical trials. Translates research discoveries into usable and marketable products.

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

  • Autonomy: 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: June 30, 2021, 6:19 am
Category : Software Test Engineer
Job Type : Contract
Id : 8380
Region : Twin Cities

Seeking a talented R&D Test Engineer to work within a Software Development team to help in the product development process for a major medical device company.  The position will assist with the Computer Systems Development team in component selection, qualification, and design transfer in the Electrophysiology Integrated lab systems. 

 

Duties and responsibilities:

  • Responsible for the development, qualification, and release of computer system component and software releases for  Electrophysiology Systems
  • Development of test plans protocols
  • Execution of software and computer system verification protocols
  • Enhances and documents medical device functionality
  • Collaborate with product management, customer care, quality, regulatory, production, and other engineering disciplines to deliver upon product delivery objectives and business goals 

 

Required Qualifications:

  • Minimum of Associates' degree in engineering, computer science, information technology, or related fields. 
  • Preferred 1 to 5 years' experience in engineering, computer science, information technology, or related fields. 
  • Experience with development of test plans/methods/protocols
  • Experience executing test methods/protocols on hardware and software projects
  • Experience working with high-end workstations, network hardware, internal cards like frame grabbers and external accessories like printers, monitors, touchscreens, etc.
  • Capable of producing polished, detail-oriented written technical documentation
  • Strong analytical and problem-solving skills
  • Organized and on-time with ability to work in a structured process environment
  • Ability to engage with and successfully influence cross functional teams

 

Preferred Qualifications:

  • Experience with non-product software validation
  • Experience with engineering change process and enterprise/document management systems such as Windchill
  • Experience with Word, Visio, and similar documentation tools
  • Familiarity with EMC/EMI & Safety testing
  • Familiarity with software revision control system
  • Familiarity Microsoft Windows and Linux Operating System installation and configuration, including driver troubleshooting and OS enhancements
  • Familiarity with the EP space including examining ECG waveforms, fluoroscopy, and ultrasound sources


Posted: June 29, 2021, 1:24 pm
Category : Electrical Engineer
Job Type : Contract-to-Hire
Id : 8376
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: June 25, 2021, 12:06 pm
Category : Mechanical Engineer
Job Type : Permanent
Id : 8375
Region : Twin Cities

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

Essential Duties and Responsibilities:

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

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

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

Supervisory Responsibilities:

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

Education/Experience:

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


Posted: June 25, 2021, 11:25 am
Category : Electrical Engineering
Job Type : Permanent
Id : 8374
Region : Twin Cities

Great opportunity for an Electrical Engineering Manager who will be responsible for leading and supervising a team of highly skilled electrical engineers and technicians as they provide technical solutions to address our customers challenging medical device development programs. These programs include complex electromechanical systems from mobile health devices to implantables.

Essential Duties and Responsibilities:

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

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

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

The requirements listed below are representative of the knowledge, skill, and/or ability required:

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


Posted: June 25, 2021, 11:18 am
Category : Electrical Engineer
Job Type : Contract-to-Hire
Id : 8373
Region : Twin Cities

Seeking a Hardware Engineer for a Hardware FPGA/ DSP Engineering role that will include working at Board Level Hardware and FPGA design. Typical responsibilities will include System architecture.

HDL coding in Verilog or VHDL, Synthesis, timing closure and bit-stream proving. The role will also include usage of debugging tools on Altera Signal tap Logic analyzer or Xilinx, Chipscope, FPGA-Embedded processors. Working closely with industrial design on form-factor requirements, constraints and board bring up and Validation, coordinating with testing team for bring up and on the FPGA front.

POSITION REQUIREMENTS:

  • Over 4/5 years of professional experience as FPGA Research Engineer with strong expertise in designing, synthesizing and verifying complex FPGAs using VHDL/Verilog , simulation tools, and in-lab debugging, timing closure.
  • Knowledge on Processors, TCP/IP networking, image processing/DSP algorithms on FPGAs.
  • Experience with FPGA-embedded processors (MicroBlaze, NiosII, PicoBlaze)
  • Good insight into Electronics fundamentals.
  • Understanding of the typical project flow on both board design and FPGA design
  • Exposure to Altera Quartus environment or Xilinx ISE environment for complete FPGA implementation.
  • Good understanding of either Analog design or Digital Signal Processing is a plus.
  • Good insight into working with Matlab Toolbox.


Posted: June 25, 2021, 11:13 am
Category : Project Manager
Job Type : Contract
Id : 8366
Region : Twin Cities

The R&D Engineering Project Manager is responsible for implementing and maintaining the effectiveness of the quality system for a major medical device company.

  • Executes to defined business results expected from a project. Is responsible and accountable for achieving those results; where results are expressed in terms of compliance with Design Control and/or Change Control policies; quality; time; scope and cost. A project is a set of interrelated tasks that culminates in clearly defined business results. For new product development projects; the business results will typically include the launch of one or more products. Differences across the levels of Project Manager are dependent upon increasing project complexity and increasing level of expected independence. Each higher level incorporates the expectations from the lower levels. Manage moderately complex project or several smaller low complexity projects with the assistance from their manager.
  • Provides risk assessments (both safety and project related) and communicates critical issues impacting product quality to management (Q01 and Q04.01.004)). Establish and maintain risk analysis as part of overall responsibility to control / reduce risk (QO4.01.001) Recognizes strategy; quantifies and evaluates risks; recommends actions and develops contingencies to cope with various scenarios. Able to analyze risk / reward trade-offs and make recommendations of appropriate path forward.
  • Translates project ADD goals into the day-to-day activities necessary to accomplish them.

Required Education: Bachelor degree in a discipline appropriate to the project environment.

Required Years Experience: 7 yrs. +



Posted: June 18, 2021, 7:01 am
Category : Quality Engineering
Job Type : Contract
Id : 8361
Region : Twin Cities

A Risk Management Engineer assures new or modified products perform the functions intended in a safe manner and establishes compliance with the quality system. They collaborate with clinical, design engineering, regulatory, labeling, and post market surveillance functions to ensure that risk is appropriately mitigated, evaluated, disclosed, and monitored. They are responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient/user safety and meeting business needs.

Job Duties:

  • Execute and support on-time completion of Risk Management Deliverables (RMP/RMR, HA, DFMEA, UFMEA, and complaint data review/analysis).
  • Maintain Risk Management deliverables to ensure continued acceptability of product based on post market feedback. Evaluate and update the Use, Design and Process FMEAs.
  • Drive creation of risk mitigation strategy and support the establishment of objective, measurable, discrete, and verifiable customer and product requirements to meet that strategy.
  • Complete Document Change Request Reviews in a timely and objective manner
  • Additional duties may be identified by functional management based on the current project/business objectives.
  • 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:

  • Bachelor level degree in Engineering or Technical Field, advance degree preferred
  • 3 - 6 years’ experience Risk Management process, Design Controls, Complaints Investigations.
  • Solid communication and interpersonal skills
  • 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.


Posted: June 15, 2021, 7:04 am
Category : Reliability Engineer
Job Type : Contract
Id : 8360
Region : Twin Cities

Seeking a Sr. Reliability Engineer to support the planning, execution, documentation, and approval of test method validation and design verification studies for a major medical device company.

Responsibilities:

  • Create and modify risk analysis documentation to support design of new processes and products.
  • Ensure compliance with relevant safety regulations, QSRs, ISO Standards, EU MDR, MDD, Quality Business System and Key Corporate Policies
  • Review and approve changes to designs/processes and assess impact on product and qualification status
  • Providing input for Regulatory submissions
  • Responsible for addressing assigned CAPA activities and ensuring that established timelines are met

Requirements:

  • Medical device experience,
  • Risk management experience
  • Test method development and validation
  • Education Required: Min BS biomedical engineer, BS mechanical engineering or BS electrical engineering
  • Years’ Experience required: 3-5 years


Posted: June 11, 2021, 9:20 am
Category : Mechanical Engineer
Job Type : Contract
Id : 8347
Region : Twin Cities

Seeking a Principal Mechanical Design Engineer with catheter design expertise and a Technical Leader skillset. This individual will provide the skills, knowledge and experience with cross-functional teams, on the subject of catheter design. The candidate will lead the technical development of a catheter portion of a therapy, and must lead and coordinate engagement with associated teams (project managers, part characterization testing, animal testing, sourcing, materials, manufacturing, reliability, etc.) to meet application, business and customer requirements.

This position will orchestrate the identification of technical strategies, solving of technical problems and completion of deliverables, among team members both internal and external to the design group. React to challenges, set-backs, scope-changes, etc., formulating an action plan, and leading the design team to forge a new path forward. Lead, direct, and/or review the work of technical team to execute the technical plan.

POSITION RESPONSIBILITIES

  • Design, develop, analyze, troubleshoot and provide technical skills during research and/or product development
  • Translate customer needs to device or therapy concepts
  • Create prototype concepts and lead down selection process for final concept
  • Institute design changes based on internal and external customer feedback
  • Perform job functions in accordance with applicable GMP and ISO standards
  • Comply with applicable FDA and international regulatory laws and standards
  • While working with other team members, complete the deliverables such as VOx Assessment, Solution Definition, Risk Register, Design Input Requirements, Design Specification, Print generation, Design Characterization/DRM tasks, Solution Definition TAC, Design Validation, Process Planning Matrix, regulatory submission-ready documents for the FDA and other regulatory bodies, and others as necessary. While ultimately accountable for these tasks, may delegate responsibility as appropriate for individual deliverables.
  • Write protocols, reports, and presentation of analytical and interpretative nature to communicate results
  • Designs studies to investigate specific performance and therapy attributes
  • Responsible for technical execution of experiments utilizing DRM methodologies; define and develop tests and test methods to meet product requirements
  • Define QMS approach such as to leverage designs/documentation
  • Assess the performance of developed devices through execution of structured experimental plans to drive data-based decisions
  • Perform risk / failure mode assessment, plan and conduct performance and safety testing and ensure mitigations are in place for designs
  • Partake in verification and validation of designs and processes

POSITION REQUIREMENTS

  • Bachelors degree with 10+ years experience
  • Catheter design
  • Pullwire/deflectable experience
  • Bench test and test method experience
  • Risk burn down methodology
  • Agile experience
  • Design control experience
  • Understand anatomy, disease states, clinical use cases and user interface requirements and using these to drive the definition of product requirements
  • Interact and build relationships with physicians as well as sales and marketing partners


Posted: May 27, 2021, 1:43 pm
Category : Systems Engineer
Job Type : Contract-to-Hire
Id : 8344
Region : Twin Cities

We are looking for a talented Systems Engineer to succeed and grow with us as we create the next generation of medical devices. Individuals seeking the ability to apply their talents towards unique, effective, and economical device solutions must apply. Our engineering services group values innovative and creative people who are looking for the challenges found in a diverse product portfolio. As a valued employee, you will join a dedicated team bringing the next generation of Medical Devices to market.

Successful candidates for this role are responsible for ensuring technical solutions meet stakeholder’s needs, standards, and industry practices. Ensure that solutions address our customers challenging medical device development needs, and translate needs into clearly defined, verifiable deliverables. The Systems Engineer will collaborate with teams to define solutions, architectures, interfaces, scope and other high level and multi-disciplinary needs of programs. These programs include complex electromechanical systems from mobile health devices to implantables.

Position Responsibilities:

  • Lead systems engineering efforts and drive related deliverables on multiple projects.
  • Develop design input/output requirements and ensure solid rationales
  • Ensure compliance to standards.
  • Gather and prioritize stakeholder needs.
  • Lead systems architecture concept development sessions; create rating criteria for concept ranking and acceptance of early architectural concepts.
  • Translate design inputs into functional requirements and ensure they are properly translated to design outputs
  • Capture systems design inputs, outputs, and rationales.
  • Lead formal planning, assist with design and test method identification and development.
  • Lead multi-disciplinary design reviews

To be considered for this opportunity, you must have:

  • A Bachelor of Science degree in a science related field, and a minimum of 8 years of experience (5 in systems or multi-disciplinary) with demonstrated success in medical product development.
  • Knowledge of medical device regulations and standards (examples: 21 CFR, ISO 13485, ISO 14971, IEC62304, etc.).
  • Comprehensive knowledge of systems engineering in a regulated field is a must.


Posted: May 24, 2021, 12:24 pm
Category : Mechanical Engineer
Job Type : Contract-to-Hire
Id : 8343
Region : Twin Cities

We are looking for a talented Senior Mechanical Engineer to succeed and grow with us as we create the next generation of medical devices.  Individuals seeking the ability to apply their talents towards unique, effective, and economical device solutions must apply. Our engineering services group values innovative and creative people who are looking for the challenges found in a diverse product portfolio.  As a valued employee, you will join a dedicated team bringing the next generation of Medical Devices to market.

 

The Senior Mechanical Engineer, you will:

  • Lead product design development.
  • Lead and complete key DHF document deliverables.
  • Work with suppliers and manufacturing facilities to design for manufacturability.
  • Identify and efficiently resolve technical problems and issue.
  • Lead and communicate to a client for small scale programs.
  • Research and analyze experimental data to understand design issues and set a direction for issue resolution.

 

Education/Experience:

  • Bachelor's degree in Mechanical Engineering or equivalent (Master's degree preferred);
  • 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. 
  • Experience in medical device design or other regulated industries. 
  • Must have working knowledge of CAD.
  • Must have demonstrated experience working on electromechanical systems. 
  • Prefer experience with IEC 60601-1 and with ISO 14971 Risk Management for Medical Devices.
  • Must have experience working in teams with multiple engineering disciplines and external 3rd parties and ability to manage multiple priorities.


Posted: May 24, 2021, 12:20 pm
Category : Technical Writer
Job Type : Contract
Id : 8342
Region : Twin Cities

The Engineering Technical Writer creates, develops, plans, writes and edits operational, instructional, maintenance or test procedures for paper, multimedia, web-based publications and user sites; may produce content for embedded user assistance technology. Conducts interviews with various users and technical staff to gather data for documentation. Researches and translates technical information into manuals and/or web-based documents for nontechnical and technical users. May document engineering processes and specifications. Recommends formats responsive to technical and customer requirements. Produces products that conform to the company documentation and quality assurance standards.Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University).Autonomy: Established and productive individual contributor. Works independently with general supervision on larger, moderately complex projects / assignments.Organizational Impact: Sets objectives for own job area to meet the objectives of projects and assignments. Contributes to the completion of project milestones. May have some involvement in cross functional assignments.Innovation and Complexity: Problems and issues faced are general, and may require understanding of broader set of issues or other job areas but typically are not complex. Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area.Communication and Influence: Communicates primarily and frequently with internal contacts. External interactions are less complex or problem solving in nature. Contacts others to share information, status, needs and issues in order to inform, gain input, and support decision making.Leadership and Talent Management: May provide guidance and assistance to entry level professionals and / or employee in Support Career Stream.Required Knowledge and Experience: Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience. Requires a University Degree and minimum of 2 years of relevant experience, or advanced degree with 0 years of experience.

Posted: May 21, 2021, 1:41 pm
Category : R&D Engineer
Job Type : Contract
Id : 8340
Region : Twin Cities

Seeking an R&D Engineer to design, develop and provide technical expertise in the research and development (R&D) of peripheral embolization medical devices from conception. Support engineering teams through planning, prototyping, literature review, performing testing and analysis, and troubleshooting. Partner with Quality, internal Manufacturing, Suppliers, Marketing, Regulatory Affairs, and other key functions to achieve business goals.

This role is an individual contributor within the Peripheral Vascular Health operating unit, which employs the full breadth of our talent, technologies, products, services, and solutions to address the needs of customers and patients across the globe. We focus on transforming global vascular disease management.

A Day in a Life

  • As an R&D Engineer, you will focus on delivering R&D to new therapies, while adhering to policies using specialized knowledge and skills. The role requires effective management and prioritization of multiple concurrent tasks in an ambiguous environment. Responsibilities may include the following and other duties may be assigned:
  • Develop and coordinate small projects, as asked by the project team, with supervision from higher level engineering;
  • Assist in developing customer and product specifications;
  • Develop, troubleshoot, qualify, and/or validate fixtures, equipment, and test methods utilized to evaluate product design;
  • Assist in preparing engineering drawings with specifications and tolerances;
  • Create test plans/protocols, build prototypes, perform testing, and analyze and document results;
  • Process engineering change orders;
  • Assist in developing Failure Modes, Effects, and Criticality Analyses;
  • Present technical findings or task status to cross functional teams through meeting minutes, presentations, design reviews and other means of communication;
  • Perform job functions in accordance with applicable GMP and ISO standards;
  • Maintain required documentation per GDP procedures.

Must Have – Minimum Qualifications

  • 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 2 years of relevant experience, or advanced degree with 0 years of experience.

Nice to Have

  • Degree related to Bio-engineering, Biomedical Engineering, Mechanical Engineering, or Materials Science & Engineering;
  • Minimum 1 year experience in medical device industry with Class II or III product systems, preferably with vascular therapies, products, and technologies (e.g. disposable syringes, catheters, liquid embolics);
  • Working knowledge of rapid prototyping and product design;
  • Experience with equipment and fixture development and qualification, test method development and validation, and design verification and validation testing;
  • Experience with medical device material characterization and selection (e.g. polymers, ceramics);
  • Ability to compile, organize, and communicate technical data using Excel, Word, Visio, and PowerPoint;
  • Experience using statistical techniques (e.g. DOE, Monte Carlo, ANOVA, Gage R&R, or Six Sigma tools and principles);
  • Experience using common engineering software (e.g. CAD - SolidWorks, Statistical – Minitab or JMP, MATLAB, PLM – Agile, Enovia or Windchill).


Posted: May 18, 2021, 11:02 am
Category : Electrical Engineer
Job Type : Permanent
Id : 8338
Region : Twin Cities

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

Core Responsibilities:

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

Experience, Education and Competencies Required

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

Preferred Experience

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


Posted: May 18, 2021, 9:39 am
Category : Software Engineer
Job Type : Contract
Id : 8336
Region : Twin Cities

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

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

  • Autonomy: 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 (BS in Computer Engineering) and minimum of 2 years of relevant experience, or advanced degree with 0 years of experience.


Posted: May 18, 2021, 6:28 am
Category : BioMedical Engineer
Job Type : Contract
Id : 8333
Region : Twin Cities

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

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

Position Requirements:

  • Bachelor’s degree in a relevant field
  • Experience with Biocompatibility, Medical device, Submissions to notified bodies
  • Years’ Experience Required: For senior engineer, requires a University Degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience. For principal engineer, requires a University Degree and minimum of 7 years of relevant experience, or advanced degree with a minimum of 5 years relevant experience.


Posted: May 14, 2021, 6:25 am
Category : BioMedical Engineer
Job Type : Contract
Id : 8332
Region : Twin Cities

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

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

Position Requirements:

  • Bachelors degree in a relevant field
  • Experience with Biocompatibility, Medical device, Submissions to notified bodies
  • Years’ Experience Required: For senior engineer, requires a University Degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience. For principal engineer, requires a University Degree and minimum of 7 years of relevant experience, or advanced degree with a minimum of 5 years relevant experience.


Posted: May 14, 2021, 6:17 am
Category : Manufacturing Engineer
Job Type : Contract
Id : 8331
Region : Twin Cities

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

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

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


Posted: May 13, 2021, 2:02 pm
Category : Manufacturing Engineer
Job Type : Contract
Id : 8330
Region : Twin Cities

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

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

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


Posted: May 13, 2021, 1:57 pm
Category : Packaging Engineer
Job Type : Contract
Id : 8327
Region : Twin Cities

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

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

  • Autonomy: 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 1 years of relevant experience, or advanced degree with 0 years of experience


Posted: May 13, 2021, 6:28 am
Category : Manager
Job Type : Contract
Id : 8320
Region : Twin Cities

The Program Manager oversees and manages the operational aspects of ongoing projects and serves as liaison between project management and planning, project team, and line management for a major medical device company. Manages the development and implementation process of a company's products and services involving departmental or cross-functional teams focused on the delivery of new or existing products. Reviews status of projects and budgets; manages schedules and prepares status reports. Monitors the project from initiation through delivery. Assesses project issues and develops resolutions 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.

Management and supervisory professionals with one or more employees who are focused on tactical, operational and some strategic activities within a specified area. Levels within the management career stream typically have six or more direct reports. The majority of time is spent overseeing their area of responsibility, managing performance, developing talent, engagement and inclusion, communicating business and operational developments, planning, prioritizing and / or directing the responsibilities of direct reports. Goal achievement is typically accomplished through performance of direct and / or indirect reports. A key responsibility of roles in this career stream is managing people. which includes: accountability for mentoring, developing and coaching staff on meeting/exceeding performance expectations and defined objectives, providing leadership to staff ensuring the prioritization of strategic and department level initiatives to include defining performance goals and targets, conducting performance reviews, and staff 1:1s to guide performance management and employee development efforts and manage toward departmental goals.

  • Autonomy: Manages subordinate supervisors and/or experienced professionals who exercise latitude and independence in assignments. Provides tactical and / or operational leadership and coaching. Receives assignments in task and objective oriented terms.
  • Organizational Impact: Establishes operational plans and implements policies and strategies. Decisions impact program schedules, customer satisfaction levels, or allocation of time, material resources, expenditures and funds. May have budget or P&L accountability for a department, function or geography. Strive for continuous improvement and consistency in deliverables.
  • 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. Authorizes hiring, firing, promotion and reward within own area.
  • 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. Requires a University Degree and minimum of 5 years relevant experience, or advanced degree with a minimum of 3 years prior relevant experience.


Posted: May 11, 2021, 9:57 am
Category : Technical Writer
Job Type : Contract
Id : 8316
Region : Twin Cities

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

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

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


Posted: May 7, 2021, 12:36 pm
Category : Software Engineer
Job Type : Contract
Id : 8315
Region : Twin Cities

Seeking a Machine Learning Engineer / Software Engineer to develop the next-generation technologies that revolutionize the care of millions of patients worldwide. Our products range from complex cloud-based information processing at massive scale to efficient algorithms controlling the real-time operation of implanted medical devices. We are looking for engineers who bring fresh ideas from all areas, including artificial intelligence, computer vision, signal processing, natural language processing, information retrieval, distributed computing, UI design and mobile. As a Machine Learning engineer, you will work on multiple projects critical to the company. Our engineers need to be versatile, display leadership qualities and be enthusiastic to take on new problems across the full-stack as we continue to push technology forward.

Responsibilities:

  • Design, build, train and test ML models
  • Work closely with Project Managers, Research Scientists, and fellow ML Engineers to frame problems within the business context
  • Analyze experimental and observational data, communicate findings, and facilitate product design decisions

Qualifications:

  • B.S., M.S. or Ph.D. in Computer Science, Statistics, Biomedical Engineering or related technical field
  • Experience with signal and image processing
  • A solid understanding of both probability and statistics
  • Advanced experience with building AI architectures: Convolutions, Residuals, Recurrence, and Transformers
  • Deep knowledge of techniques such as: Transfer learning, Data Augmentation, Reinforcement learning, Generative Adversarial Networks, Natural Language Processing, and Image Segmentation
  • Strong grasp of semi-supervised approaches such as Contrastive Learning and Student-Teacher methods
  • Proven ability to quickly and effectively turn research ML papers into working code
  • Experience with other ML techniques such as Gaussian processes, Bayesian methods, Boosted Trees, SVMs, Random Forests, and PCA
  • Extensive knowledge of ML evaluation metrics and best practices
  • A firm understanding of mathematics and linear algebra, including the theory behind algorithms such as backpropagation and Adaptive Moment Estimation (Adam)
  • Deep understanding of python and object-oriented coding
  • Practical knowledge of ML libraries such as PyTorch, Tensorflow, Scikit-Learn, etc.
  • Standard software development skills such as code version control (Git)
  • SysAdmin skills in cross-platform shell scripting
  • Data pipeline and wrangling expertise with SQL and technologies such as Spark and Hadoop
  • Working knowledge of how to build efficient end-to-end ML workflows, TFX
  • Collaborate well with others
  • Work in a team environment with code reviews and feedback from peers
  • Excellent communication skills
  • Self-driven with the ability to deliver on ambiguous projects with incomplete or dirty data


Posted: May 6, 2021, 10:28 am
Category : Quality Engineer - Medical Device
Job Type : Contract
Id : 8312
Region : Twin Cities

The Quality Engineer develops, modifies, applies, and maintains quality standards and procedures for processing/analyzing customer returned product. Collaborates with development to ensure quality standards and procedures for product analysis/repair are in place prior to new product introductions. Devises and implements procedures for inspecting, testing, and evaluating the functionality of customer returns. Designs, specifies, acquires, and implements inspection and testing mechanisms and equipment. Evaluates, selects, and orders test equipment that is most appropriate and cost effective for the analysis of customer returned product. Oversees the installation, modification, upgrade, and maintenance of test equipment. Conducts quality assurance tests and performs statistical analyses to assess the cost of and determine the responsibility for products or materials that do not meet specifications. Ensures that corrective and preventive measures (CAPAs) meet acceptable reliability standards and that documentation is compliant with requirements. May specialize in the areas of test design, material flow, production control, product evaluation and reliability, inventory control and/or research and development as deemed appropriate.

Typically, an individual contributor with responsibility to a professional discipline or specialty. Delivers and/or manages projects assigned and works with collaborators and stakeholder to achieve desired results. May act as a mentor to colleagues or direct the work of other professionals. Most time is spent delivering and overseeing projects through to completion while adhering to policies. Uses specialized knowledge and skills normally acquired through advanced (typically university level) education.

  • Autonomy: Works independently under limited supervision to determine and develop strategic approaches/solutions to problems.
  • 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. Provides in-depth analyses and recommendations on process improvements.
  • Communication and Influence: Communicates with senior internal and external customers and vendors. Exchanges information, statuses, ideas, and issues to achieve objectives, and influence decision-making.
  • Leadership and Talent Management: May provide guidance, coaching, and training to other employees within job area.
  • Required Knowledge and Experience: Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience. Requires working knowledge of project management skills/techniques. Requires a university degree and minimum of 3 years of relevant experience, or advanced degree with a minimum of 1 year of relevant experience.


Posted: May 5, 2021, 6:26 am
Category : Technicians
Job Type : Contract-to-Hire
Id : 8309
Region : Twin Cities

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

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

Tasks:

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

Skills and Requirements:

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


Posted: May 4, 2021, 9:38 am
Category : Quality/Regulatory
Job Type : Contract
Id : 8305
Region : Twin Cities

In this exciting role as a Senior Reliability Engineer you will have responsibility for planning and leading product Firmware and Electrical reliability and safety technical assessments and compliance activities to ensure that reliability and safety is proactively designed into our products, that potential risks are analyzed and controlled, and that product/system performance is quantifiably predicted. Your work will span the product development lifecycle from technology through development and early market release of new and derivative products.

A Day in the Life

  • Responsibilities may include the following and other duties may be assigned:
  • Plan, lead, execute, and integrate Design for Reliability (DfR), to quantify product reliability.
  • Develop test plans and work with test lab to demonstrate reliability and adherence to standards. May determine units and/or batches requiring environmental testing and specify minimum number of samples to obtain statistically valid data. Write test reports in a format that adequately meets regulatory guidelines.
  • Interact with design partners to understand product design, especially for novel features. Evaluate design for potential failure modes. As necessary, proposes changes in design or formulation to improve system and/or process reliability.
  • Complete risk analysis studies of new firmware and/or electrical design and processes. Develop mitigations of risk in conjunction with Design team.
  • Ensure that corrective measures meet acceptable reliability standards.
  • Advocate for Quality in design reviews and other project meetings
  • Responsibilities may include the following and other duties may be assigned.
  • Develops, coordinates and conducts technical reliability studies and evaluations of engineering design concepts and design of experiments (DOE) constructs.
  • Recommends design or test methods and statistical process control procedures for achieving required levels of product reliability.
  • Completes risk analysis studies of new design and processes.
  • Compiles and analyzes performance reports and process control statistics; investigates and analyzes relevant variables potentially affecting product and processes.
  • Ensures that corrective measures meet acceptable reliability standards.
  • Analyzes preliminary plans and develops reliability engineering programs to achieve company, customer and governmental agency reliability objectives.
  • May develop mathematical models to identify units, batches or processes posing excessive failure risks.
  • As necessary, proposes changes in design or formulation to improve system and/or process reliability.
  • May determine units and/or batches requiring environmental testing, and specifies minimum number of samples to obtain statistically valid data.

Qualifications - Must Have: Minimum Requirements

  • Bachelors degree required
  • Minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience

Qualifications - Nice to Have:

  • Advanced degree in Electrical Engineering, Computer Engineering, Computer Science; or suitable firmware, software, electrical design, or reliability experience with Biomedical Engineering, Safety Engineering, or Clinical/Field Support experience.
  • Experience in a highly regulated industry, preferably implantable medical devices.
  • Experience with 21 CFR Part 820 (Quality System Regulation), ISO 13485, EN 45502/ISO 14708, IEC 60601, ISO 14971, hazard analysis and risk analysis techniques (e.g., FTA, DFMEA, Risk Management Report), and/or IBHRE Certified EP Specialist (Allied Professional).
  • Certification (belts) in Design for Reliability and Manufacturability (DRM) or Design for Six Sigma (DFSS). ASQ CRE certified.


Posted: April 29, 2021, 1:30 pm
Category : Quality/Regulatory
Job Type : Contract
Id : 8295
Region : Twin Cities

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

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

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


Posted: April 23, 2021, 6:34 am
Category : Manufacturing Engineer
Job Type : Contract
Id : 8287
Region : Twin Cities

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

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

  • Autonomy: 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: April 19, 2021, 12:33 pm
Category : Software Engineer
Job Type : Contract
Id : 8275
Region : Twin Cities

Seeking a Sr. Software Engineer to be responsible for the design and implementation of the Cardiac Rhythm Management (CRM) mobility platform. Create mobile applications of the highest quality by ensuring the product meets the company’s exacting standards. In this role, you will design and implement technology solutions that are leading edge, robust and best-in-class. You will need to work collaboratively with all parts of the business process as well as working with cross platform engineering teams.

Responsibilities:

  • Visionary and innovative thinker willing to push the limits of existing technology and implement new cutting edge solutions
  • Research mobility solutions that meet and exceed customer requirements
  • Coordinate with mobility vendors as necessary to arrange all steps of solution integration
  • Work closely with Systems, Quality, Regulatory and other stakeholders to collaborate effectively and deliver robust solutions
  • Develop, test and maintain mobile software solutions that deliver on project technical and timing objectives
  • Assist in identifying and organizing requirements and producing specifications for mobile application projects
  • Build prototypes, frameworks, development kits and accelerator systems suitable for engineering evaluations and testing
  • Develop and execute unit tests to ensure and maintain source code quality
  • Demonstrate quality ownership and accountability through timely corrective actions and root cause analysis
  • Conduct and/or participate in technical reviews of requirements, specifications, designs, code and other engineering artifacts, ensuring timely delivery to meet program commitments.
  • Create and maintain product documentation (requirements, specification, design, development, integration, test procedures and results)
  • Learn new skills and adopt new practices readily in order to develop innovative and low-cost products that maintain the company's technical leadership position
  • Apply and comply with the project development process as defined by the Project Manager
  • Configure mobility solution, improve mobility solution performance and use company software

Must Have: Minimum Requirements

  • Bachelor’s or Master’s degree in Software Engineering, Computer Science or related technical field.
  • 4+ years of software development experience with a Bachelor’s degree, 2+ years of software development experience with a Master’s degree.

Nice to Have:

  • Experience in the design and delivery of cross platform native mobile applications through Xamarin or associated frameworks
  • Experience in native iOS and Android, including UI development
  • Experience working in the healthcare industry and firm understanding of FDA requirements and privacy concerns
  • Detailed knowledge and extensive experience implementing Bluetooth Low Energy solutions communicating with various medical implant and wearable devices
  • Visionary and innovative thinker willing to push the limits of existing technology and implement new cutting edge solutions
  • Knowledgeable in web technologies including HTML5, CSS3, JavaScript, XML, AJAX, and REST
  • Knowledgeable in server-based technologies from cloud-provider technologies from Amazon, Microsoft or Google such as orchestration, microservices, databases and/or notification services
  • Experience implementing both image and database encryption solutions
  • Proven experience with various mobile services such as location, messaging, multi-media, etc.
  • Experience with modern software engineering concepts, the software life cycle, and application software development using a variety of technologies
  • Strong team player driven by continual improvement and motivated to elevate team efficiency and quality
  • Demonstrated proficiency in written and verbal communications


Posted: April 15, 2021, 7:41 am
Category : Systems Engineer
Job Type : Contract
Id : 8270
Region : Twin Cities

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

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

  • Autonomy: 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: April 13, 2021, 1:32 pm
Category : Quality/Regulatory
Job Type : Contract
Id : 8268
Region : Twin Cities

The Supplier Quality Engineer Provides technical engineering expertise and leadership to the Supply Management organization and suppliers, serving as the technical liaison between Company design requirements and suppliers' technical capability to assure that robust margins are achieved and maintained.

An individual contributor with responsibility in our technical functions to advance existing technology or introduce new technology and therapies. Formulates, 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 R&D, systems or initiatives related to new technologies or therapies – from design to implementation - while adhering to policies, using specialized knowledge and skills.

Responsibilities may include: facilitation of Lean-Sigma continuous improvement with suppliers, support and/or implementation of structural Early Supplier Involvement (ESI) process in new product development to achieve Design for Manufacturability and Reliability; identification of key technical capabilities of supply base; establishment of control plans and monitoring systems for supplier processes; identification and management of risk associated with low margins between supplier processes and design requirements; facilitation and reporting of progress of supplier corrective actions as assigned by relevant CAPA system; providing core team input of Design for Sourcing/Manufacturability into new designs; long term technology/supplier scanning as input into product/technology road maps.

  • 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 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 2 years of relevant experience, or advanced degree with 0 years of experience.


Posted: April 13, 2021, 11:21 am
Category : Systems Engineer
Job Type : Contract
Id : 8269
Region : Twin Cities

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

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

  • Autonomy: 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: April 13, 2021, 10:46 am
Category : Machinist
Job Type : Permanent
Id : 8264
Region : Twin Cities

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

 

Qualifications:

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

 

Knowledge and Skill Qualifications:

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

 

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

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


Posted: April 8, 2021, 1:09 pm
Category : Firmware Engineer
Job Type : Contract
Id : 8258
Region : Twin Cities

Looking for a Firmware Engineer II to join the R&D Organization to design and develop new and modifications to embedded firmware for medical device systems.

Areas of responsibilities will include firmware system design, software development in C, and design requirements and documentation.

Candidates must be able to translate design inputs into firmware design, write detailed firmware specifications, generate, and review design documentation, and interface specifications in compliance with design control procedures used within the medical device industry.  Candidates must also be willing to work in a fast paced, multi-tasking, team environment.

 

POSITION RESPONSIBILITIES

  • 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

  • 3+ years of embedded firmware/software design and development with Bachelors Degree in Engineering (Electrical or Software) or
  • 2+ years of experience with Masters Degree
  • Embedded firmware/software development in C language
  • Strong experience working with hardware, including ability to read schematics, data sheets and interface specifications
  • Strong experience developing and running unit tests using standard unit test frameworks
  • 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: April 6, 2021, 10:36 am
Category : Firmware Engineer
Job Type : Contract
Id : 8178
Region : Twin Cities

Seeking a Principal Firmware Engineering for a position within the R & D product development area. This person will provide software engineering leadership with developing and commercializing a medical device system. This position will lead and be responsible for the software architecture, design, development and test for embedded electronic device components of a neuromodulation system for treatment of chronic migraines, and will provide task scoping, design cost analysis and project planning to the R&D product development area. This person will work with other engineers and technicians to achieve project milestones and product functionality.The successful candidate will be responsible for leading a software team to plan, architect, design, develop and test firmware and software for a medical device.This position will be responsible for all deliverables associated with the software products throughout the design and development lifecycle. Design and implement critical firmware elements of the design.Responsibilities include: Requirements analyses, software architecture, design and testing, creating/approving test reports, leading design reviews and code walk-through / inspections, overseeing / delegating coding, and providing technical work direction to internal or outsourced team members and support groups to achieve project objectives. Work under general direction with significant latitude to determine technical objectives of assignments. Provide mentoring and technical assistance as required to other software engineers and technicians. Support other on-going or legacy efforts as needed. Provide recommendations for tools, technologies and processes and contribute to continuous process improvement.Position Requirements: Bachelor's degree in Computer Science, Software Engineering, Electrical Engineering, or related disciplineMinimum of 7 years of relevant experience, or advanced degree with a minimum of 5 years relevant experiencePreferred Qualifications: MS in Electrical Engineering, Computer Science, or Software Engineering and a minimum 7 years engineering experience with at least 5 years of professional software development Expertise in development of firmware for real-time, embedded applications using C, C++, or equivalent languages. Experience developing algorithms, wired and wireless communication interfaces and sensor interfaces. Experience with driver development, motor control, pressure sensing and position sensing, energy delivery control, GUI design. Working knowledge of boot loaders, executives, schedulers, and real-time operating systems. Skilled at using oscilloscopes, logic analyzers and other tools to analyze and debug embedded systems. Solid communication, presentation, technical writing, and organizational skills. Experience developing software for embedded active implantable such as pacemakers, defibrillators, heart failure, or neuromodulation implantable devices. Experience developing software for embedded external instruments such as patient programmers, clinician programmers, implantable device rechargers, and patient monitors. Design and implement firmware modules for microcontrollers using Assembly and C programming language Experience working with ARM Cortex-M processors. Experience working with proprietary wireless communications systems. Experience working with battery powered systems and performing power optimization. Experience developing US FDA Class III medical devices. Knowledge of IEC 62304. Experience working with IAR Embedded Workbench for ARM and EWARM toolchain. Source code management using Git or similar tools. Defect and issue tracking using JIRA or similar tools. Programming Languages: C, C#, Python Experience developing bare-metal drivers for Microcontroller peripherals (Examples: UART, I2C, SPI, DAC, ADC, comparators). Knowledge of how to use an oscilloscope, logic analyzer, function generator, JTAG debugger and other electronics laboratory equipment.

Posted: February 15, 2021, 1:19 pm
Category : Firmware Engineer
Job Type : Contract-to-Hire
Id : 8172
Region : Twin Cities

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

DUTIES AND RESPONSIBILITIES:

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

QUALIFICATIONS:

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

COMPETENCIES:

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


Posted: February 11, 2021, 12:47 pm
Category : Quality Engineer - Medical Device
Job Type : Contract
Id : 8127
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 for a major medical device company. Collaborates with engineering and manufacturing functions to ensure quality standards are in place. Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment. Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications. Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements. May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.

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

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


Posted: January 14, 2021, 6:36 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 : 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 : 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 : 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