Senior Development Engineer

Genesis Innovation Group, Inc. is hiring a Senior Development Engineer II to lead medical and surgical product development from initial concept through production. The role includes project leadership, design and testing, regulatory planning, and collaboration with surgeons and cross-functional teams.

Responsibilities:

• 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

Requirements:

• Bachelor of Science in Engineering or related degree required
• Specific Medical design experience required
• Minimum of 7 years in medical (orthopedics) product development or a related field with demonstrated industry knowledge
• 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
• advanced degree preferred
• Experience with Design Controls and Risk Management preferred