Senior Development Engineer

Posted 2 days ago

genesis innovation groupDenver (CO)

Bioengineers and Biomedical Engineers Surgical Appliance and Supplies Manufacturing

SENIORITY

Manager

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About the role

Senior Development Engineer IIWe 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%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.

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