Senior Medical Device Development Engineer

Genesis Innovation Group, Inc.; Grand Rapids (MI); On-site; USD 110,000 - 150,000; Full time

Job summary

Genesis Innovation Group, Inc. in Grand Rapids, MI seeks a Senior Development Engineer II to lead the design, development, and testing of medical and surgical components from concept to production.

The role requires collaboration with surgeons and cross-functional teams, strong CAD skills, and expertise in design controls and risk management; travel up to 40% is expected. An advanced degree is preferred and 7+ years in orthopedic medical device development is desired.

Qualifications

• Bachelor of Science in Engineering or related degree required.
• Specific Medical design experience required.
• Minimum of 7 years in medical (orthopedics) product development or related field.
• Experience with Design Controls and Risk Management preferred.
• Empathize with surgeons and users to guide decision-making.
• Ability to work individually and on a team.
• Strong written post-training reports and metrics.
• High attention to detail.
• Travel up to 40%.

Responsibilities

• Lead projects from concept through production, ensuring timely completion.
• Interact with surgeon customers to discuss improvements and new ideas.
• Coordinate with cross-functional teams for alignment.
• Create project plans and assign tasks to team members.
• Monitor team work and budgets for quality and efficiency.
• Own regulatory clearance planning and documentation strategy.
• Maintain regulatory submissions and quality management documentation.
• Develop medical components, equipment, and instruments from design to realization.
• Conduct tests to evaluate performance, safety, and functionality.
• Troubleshoot issues during testing and propose solutions.
• Build relationships with surgeons, clients, and suppliers.
• Drive continuous improvements in product quality and processes.

Skills

Medical device design

Design controls

Risk management

Project management

CAD modeling

Testing & verification

Cross-functional collaboration

Regulatory familiarity

Technical documentation

Surgeon interaction

Education

Bachelor's degree in Engineering or related field

Advanced degree preferred (MS/PhD)

Tools

CAD software

Job description

Genesis Innovation Group, Inc. in Grand Rapids, MI seeks a Senior Development Engineer II to lead the design, development, and testing of medical and surgical components from concept to production.

The role requires collaboration with surgeons and cross-functional teams, strong CAD skills, and expertise in design controls and risk management; travel up to 40% is expected. An advanced degree is preferred and 7+ years in orthopedic medical device development is desired.