Job Description
Job Title: Senior R&D Engineer Location: Minneapolis, MN (Onsite – 4 days/week) Employment Type: Contract (W-2 Only) Duration: 6+ Months Contract with potential for extension Job Summary We are seeking a Senior R&D Engineer to support integration-focused medical device development activities for a leading healthcare client in the greater Minneapolis area. This role will lead technical integration efforts, support design and development activities, and collaborate with cross-functional teams to ensure successful incorporation of new technologies into existing systems. The ideal candidate will have strong experience in catheter or single-use medical device development, design controls, and regulated product development environments. Responsibilities Lead integration workstreams including interface definition, technical planning, requirements alignment, and execution activities Develop and maintain design control documentation including user needs, design inputs/outputs, traceability matrices, risk management files, verification and validation documentation, and DHF records Conduct feasibility studies, prototype development, and engineering evaluations to support product integration activities Identify, investigate, and resolve technical issues through structured problem-solving and root cause analysis methodologies Collaborate with quality, manufacturing, regulatory, supplier engineering, and cross-functional stakeholders to support project objectives Support product change activities and ensure compliance with internal procedures and applicable regulatory requirements Participate in design reviews, technical discussions, and project planning activities Communicate technical information clearly to internal and external stakeholders Required Qualifications Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, Materials Science, or a related engineering discipline Minimum 6 years of medical device industry experience, or 4 years with an advanced degree Experience with catheter and/or single-use medical device development Strong understanding of design controls, risk management, DHF documentation, verification and validation activities, and traceability requirements Experience working in FDA-regulated and/or ISO-regulated environments Strong technical problem-solving, communication, and collaboration skills Ability to work independently and manage multiple priorities in a fast-paced environment Work Requirements Ability to work onsite in the greater Minneapolis area four days per week Ability to travel up to 15% as needed Must be legally authorized to work in the United States at the time of hire W-2 employment only; third-party candidates and C2C arrangements will not be considered Salary/Rate: $45.00 – $50.00 per hour on a W-2 basis. The compensation range provided is a good-faith estimate based on the expected qualifications, experience, skills, education, geographic location, and market conditions at the time of posting. Compensation may vary within the stated range. Benefits: This is a contract position. Employer-provided benefits are not included unless otherwise required by applicable law. Equal Opportunity Employer: We are committed to creating an inclusive and equitable workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, creed, sex, gender identity or expression, sexual orientation, national origin, ancestry, age, disability, veteran status, marital status, genetic information, citizenship status, or any other characteristic protected by applicable federal, state, or local law. Application: Qualified candidates are encouraged to apply with an updated resume highlighting relevant medical device development and integration experience. Only candidates whose qualifications closely match the requirements of the position may be contacted for further consideration.