Senior Development Engineer

Genesis Innovation Group•Grand Rapids, MI

About The Position

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.

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

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