Lead Development Engineer

Job Summary

A company is looking for a Lead Development/QMS Engineer for orthopedic minimal invasive therapy devices.

Key Responsibilities:

• Lead the full life cycle development of orthopedic minimal invasive therapy devices
• Collaborate with the Chief Medical Officer to assess clinical needs and manage product development programs
• Oversee internal and external engineering and manufacturing resources, including risk management activities

Required Qualifications:

• BS in engineering (mechanical or biomedical preferred)
• 3-5 years of project leadership experience and 8-10 years of hands-on product development experience in medical devices
• Experience transitioning products into manufacturing and distribution
• Knowledge of Quality Systems, Quality Assurance best practices, and Regulatory Compliance
• Experience with orthopedic implant medical devices is desired