What are the responsibilities and job description for the Senior Research And Development Engineer - Medical Device position at Intellectt Inc?
Position: Senior R&D Engineer (Medical Device)
Location: Minneapolis, MN (Onsite)
Duration: Long-Term Contract
Overview: Our client is seeking a highly experienced Senior R&D Engineer to lead design and development efforts within a critical quality system and product integration initiative. This is a high-visibility, hands-on leadership role requiring strong technical expertise, ownership, and the ability to influence senior leadership and cross-functional teams. The ideal candidate will bring a balance of strategic leadership and execution, with proven experience driving complex engineering initiatives in a regulated environment.
Key Responsibilities:
- Lead integration workstreams including interface definition, requirements alignment, planning, and technical execution
- Drive technical decision-making in collaboration with engineering leadership
- Own and deliver design control documentation, including:
- User needs, design inputs/outputs, and traceability
- Risk management documentation and mitigation strategies
- Verification & Validation (V&V) planning and execution
- Design History File (DHF) development and maintenance
- Lead or oversee test method development and validation to support integration readiness
- Conduct feasibility studies, prototype development, and iterative testing across device platforms
- Perform root cause analysis and resolve complex technical issues
- Identify and mitigate integration risks proactively
- Collaborate cross-functionally with Quality, Manufacturing, Supplier Engineering, and Regulatory teams
- Influence stakeholders and provide technical leadership without direct reporting responsibility
Required Qualifications:
- Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, Materials Science, or related field (Master’s preferred)
- 10–15 years of relevant industry experience (hands-on leadership required)
- Strong experience in medical device product development within a design controls environment
- Experience with catheter-based and/or single-use medical devices
- Proven ability to lead technical initiatives and communicate effectively with senior leadership
- Strong knowledge of:
- Design controls and DHF documentation
- Risk management processes
- Verification & Validation (V&V), traceability, and change control
- Ability to work independently and drive initiatives with minimal supervision
- Excellent problem-solving, communication, and stakeholder management skills
Preferred Qualifications:
- Experience with Windchill or similar PLM/quality systems
- Experience with DMR deliverables (prints, BOMs, specification maps)
- Expertise in test method development and validation
- Background in balloon catheter or catheter-based systems
- Familiarity with Class II/III medical device regulations
- Experience in product/platform integration or acquisitions
- Self-driven with strong accountability and ability to operate in ambiguous environments