What are the responsibilities and job description for the Senior R&D Engineer position at Novozen Healthcare LLC?
Job Title: Senior R&D Engineer – Medical Devices
Location: Greater Minneapolis, MN (Onsite – 4 days/week)
About the Role
We are seeking a Senior R&D Engineer to lead critical design and product integration efforts within a high-impact medical device program. This role requires a hands-on technical leader who can drive execution, lead workstreams, and influence cross-functional stakeholders.
You will play a key role in shaping integration strategy and ensuring successful delivery across design, quality, and regulatory requirements.
Key Responsibilities
- Lead product and system integration activities, including requirements alignment, interface definition, and execution planning
- Drive technical decision-making across assigned deliverables
- Own design control processes, including:
- User needs, design inputs/outputs, and traceability
- Risk management and mitigation
- Verification & Validation (V&V)
- Design History File (DHF) development and maintenance
- Lead test method development and validation
- Conduct feasibility studies, prototyping, and design optimization
- Perform root cause analysis and resolve complex technical issues
- Collaborate with Quality, Regulatory, Manufacturing, and Supplier Engineering teams
- Provide technical leadership without direct people management
Required Qualifications
- Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, Materials Science, or related field
- 10 years of industry experience (strong preference for 10–15 years)
- Proven experience in medical device product development within a design controls environment
- Demonstrated ability to lead technical workstreams and drive initiatives independently
- Strong expertise in:
- Design controls & DHF
- Risk management
- Verification & Validation (V&V), traceability, and change control
- Excellent communication and stakeholder management skills
Preferred Qualifications
- Experience with catheter-based or single-use medical devices
- Familiarity with Class II/III medical device regulations
- Experience with PLM tools (e.g., Windchill)
- Experience with DMR deliverables (BOMs, drawings, specifications)
- Background in product/platform integration
- Experience in test method development and validation