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.
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%
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. Apply today for immediate and confidential consideration to become our next Senior Development Engineer II. To learn more about us, visit us online at www.genesisinnovationgroup.com.
