Engineering Director, Medical Devices & NPD

Transcend; Fridley (MN); On-site; USD 160,000 - 210,000; Full time

Job summary

A medical device company based in Fridley, MN, is seeking a hands-on Director of Engineering. This role involves leading new product programs, managing engineering teams, and ensuring compliance with FDA regulations. The Director will collaborate with various departments to drive product development from concept through launch. Candidates should have over 10 years of experience in medical devices, strong technical background, and proven success in product launches. The position offers a competitive salary and is full-time on-site.

Qualifications

• 10+ years of engineering experience in medical devices or regulated products.
• Proven success leading cross-functional product launches.
• Experience with 510(k) submissions.

Responsibilities

• Drive new product development programs from concept to launch.
• Set technical strategy and engineering priorities.
• Lead efforts across the full lifecycle of new product development.

Skills

Deep understanding of FDA regulations

Strong stakeholder-management skills

Ability to manage complex multi-disciplinary programs

Education

Bachelor’s degree in engineering or related discipline

Tools

Design controls

Risk management (ISO 14971)

Job description

A medical device company based in Fridley, MN, is seeking a hands-on Director of Engineering. This role involves leading new product programs, managing engineering teams, and ensuring compliance with FDA regulations. The Director will collaborate with various departments to drive product development from concept through launch. Candidates should have over 10 years of experience in medical devices, strong technical background, and proven success in product launches. The position offers a competitive salary and is full-time on-site.