Senior 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

We are looking to hire an experienced Senior Development Engineer II. As the Senior Development Engineer II, you will be responsible for designing, developing, and testing medical and surgical components, equipment, and instruments. This role involves leading projects from initial design conception through to production, ensuring that all products meet technical and regulatory standards.

Genesis Innovation Group (GIG) is a unique Venture Capital and Business Development firm concentrated on medical devices. Our role as investors and industry partners is to focus on the creative power of entrepreneurs by leveraging our network, resources, and experience to ensure their success. Combined, we have more than a century of experience in the medical device space, and over two hundred patents and innovations to our names.

In This Role You Will

• Travel up to 40% of the time
• Manage projects from initial concept through to production, ensuring timely completion and adherence to project goals
• Regularly interact with surgeon customers to discuss product improvements and new instrument ideas
• Coordinate with cross-functional teams to ensure technical and creative alignment
• Create project plan including assigning tasks to team members
• Monitor and review work of team members to ensure high quality work
• Manage project budgets, ensuring effective allocation of financial resources
• Monitor expenditures and adjust as necessary
• Own the regulatory clearance planning and strategy pathway to be approved by the team lead
• Maintain documentation for regulatory submissions and quality management systems
• Lead the design and development of medical and surgical components, equipment, and instruments
• Understand and make well-reasoned design decisions and tradeoffs in their area
• Create and modify detailed CAD models and technical drawings
• Deliver complex products to test labs
• Conduct tests to evaluate product performance, safety, and functionality
• Troubleshoot and resolve any issues that arise during the testing phase
• Evaluate negative or questionable test results and advises team on impact and solutions
• Build and maintain strong relationships with surgeons, clients, and suppliers
• Actively seek and incorporate feedback from stakeholders into the design and development process
• Participate in continuous improvement initiatives to enhance product quality and development processes
• Provide technical advice and weighs in on technical decisions that impact other teams or the company at large

To keep up with our fast-paced, detail-driven business qualified candidates will have:

• Bachelor of Science in Engineering or related degree required, advanced degree preferred
• Specific Medical design experience required
• Minimum of 7 years in medical (orthopedics) product development or a related field with demonstrated industry knowledge
• Experience with Design Controls and Risk Management preferred
• Ability to empathize with the user (i.e., surgeons, scrub techs, sales reps) of the implants/instruments they are producing and use that empathy to guide decision-making
• Ability to work individually and on a team
• Ability to produce well-written post-training reports and provide written metrics and feedback
• High attention to detail
• Travel up to 40%

Why Join Genesis Innovation Group

If you are looking to further your career in a pioneering and evolving industry, consider joining our team of professionals. We value and appreciate our employees and will support you with great company culture and opportunities for professional growth. At Genesis Innovation Group, we provide competitive wages, a bonus program, benefits, and strong team collaboration.