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
LOCATION
Minneapolis, MN
POSTED
6 days ago
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.