Senior Medical Development Engineer
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Job Description
Senior Development Engineer II responsible for designing and developing medical devices at Genesis Innovation Group. Leading projects from conception to production while ensuring regulatory compliance.
Responsibilities:
- 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
Requirements:
- 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
Benefits:
- Competitive wages
- Bonus program
- Benefits
- Strong team collaboration
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