Senior Development Engineer

This is a fully remote position, open to applicants in Michigan.

📋 Description

• Design, develop, and evaluate medical and surgical components, equipment, and instruments.

• Lead projects from the initial concept through to production.

• Oversee project timelines, objectives, budgets, task assignments, and expenditures.

• Engage with surgeon clients regarding product enhancements and new instrument concepts.

• Coordinate interdisciplinary teams to ensure technical and creative alignment.

• Review and monitor the work of team members to ensure quality standards.

• Take ownership of regulatory clearance planning and the strategic pathway.

• Maintain documentation for regulatory submissions and quality management systems.

• Make informed design decisions and trade-offs.

• Create and adjust detailed CAD models and technical drawings.

• Deliver intricate products to testing laboratories.

• Conduct evaluations of product performance, safety, and functionality.

• Troubleshoot testing challenges and assess any ambiguous test results.

• Build and nurture relationships with surgeons, clients, and suppliers.

• Integrate stakeholder feedback into the design and development process.

• Engage in continuous improvement initiatives.

• Provide technical guidance that impacts other teams and the organization.

⛳️ Requirements

• A Bachelor of Science in Engineering or a related field is required; an advanced degree is preferred.

• Specific experience in medical design is necessary.

• A minimum of 7 years in medical (orthopedics) product development or a related field, demonstrating industry knowledge.

• Experience with Design Controls and Risk Management is preferred.

• Ability to empathize with users, including surgeons, scrub techs, and sales representatives.

• Capability to work independently as well as collaboratively within a team.

• Proficient in producing well-written post-training reports and providing written metrics and feedback.

• Strong attention to detail.

• Willingness to travel up to 40% of the time.

🏝️ Benefits

• Bonus program.

• Comprehensive benefits.

• Competitive wages.

• Positive company culture.

• Opportunities for professional development.

• Strong team collaboration.