Senior R&D Engineer
Job in
Minneapolis, Hennepin County, Minnesota, 55400, USA
Listed on 2026-06-19
Listing for:
Stark Pharma Solutions Inc
Full Time
position Listed on 2026-06-19
Job specializations:
-
Engineering
Biomedical Engineer, Product Engineer, Quality Engineering, Systems Engineer
Job Description & How to Apply Below
Hello Professionals,
Position:Senior R&D Engineer
Location:Greater Minneapolis Area (Onsite 4 days/week)
Duration:Through End of 2026 (Possible Extension)
Key Responsibilities- Lead integration-focused design and development activities for new and existing medical device technologies
- Drive interface definition, technical planning, requirements alignment, and integration execution
- Own design control documentation including DHF, traceability, risk management, V&V, and change control activities
- Support feasibility studies, prototype builds, testing, and design optimization
- Conduct root cause analysis and resolve complex technical issues
- Collaborate with Quality, Manufacturing, Regulatory, and Supplier Engineering teams to ensure successful project execution
- Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Materials Science, or related field
- 6+ years of industry experience (or 4+ years with advanced degree)
- Experience in catheter and/or single-use medical device development
- Strong understanding of design controls, risk management, V&V, DHF, and traceability
- Proven experience leading technical work streams and working cross-functionally
- Strong communication and problem-solving skills
- Ability to travel up to 15%
- Experience with technology/product integration projects
- Background in balloon catheter or catheter-based systems
- Experience with test method development
- Knowledge of Class II/III medical device regulations and quality systems
- Self-driven professional comfortable working in fast-paced environments
Position Requirements
10+ Years
work experience
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