Biomedical Engineering, Catheterization, Change Control, Communication Skills, Cross-Functional, Document Management, Feasibility Analysis, Leadership, Manufacturing Requirements, Material Science, Mechanical Engineering, Medical Equipment, Problem Solving Skills, Project Execution, Prototyping, Quality Assurance Methodology, Regulations, Research & Development (R&D), Risk Management, Root Cause Analysis, Technical Leadership, Test Design, Test Plan/Schedule, Traceability, Willing to Travel
Hello Professionals,
This is Karthik Mutyala from Stark Pharma. We are currently hiring for a Senior R&D Engineer opportunity with one of our medical device clients in the greater Minneapolis area. This is a long-term onsite opportunity running through the end of 2026 with a strong possibility of extension.
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
Required Qualifications:
- 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 workstreams and working cross-functionally
- Strong communication and problem-solving skills
- Ability to travel up to 15%
Preferred Qualifications:
- 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
Interested candidates can share their updated resume.
If you are not interested, please feel free to refer your friends or colleagues who may be looking for an opportunity.
S
Stark Pharma Solutions Inc