Lead NPI Manufacturing Engineer, Medical Devices

ACE Partners; Minnesota; In loco; USD 110.000 - 170.000; Tempo pieno

Descrizione del lavoro

ACE Partners seeks a Manufacturing Engineering leader to drive NPI and design transfer for complex electromechanical medical devices. You will coordinate pilot builds, define cell layouts, and ensure readiness of tooling, documentation, and processes for full production.

Successful candidates will have a strong track record in FDA QSR and ISO 13485 environments, plus proven ability to lead cross-functional teams and deliver high-quality documentation and results.

Competenze

• Bachelor's degree in engineering, technical, or scientific discipline.
• Master's in a STEM field is a plus.
• Demonstrated experience leading NPI or design transfer for complex electromechanical devices.
• Experience in FDA QSR and ISO 13485 regulated medical-device environments.

Mansioni

• Lead new product introduction and design transfer for complex electromechanical medical devices from design reviews to production release.
• Plan and run pilot builds, define production cell layout, staffing, and equipment needs.
• Provide DFM/DFA feedback and lead production readiness reviews to qualify processes, tooling, and documentation.

Conoscenze

Technical writing

Cross-functional leadership

Independent work

Formazione

Bachelor's degree in Engineering

Master's degree in STEM

Strumenti

Microsoft Office

Descrizione del lavoro

ACE Partners seeks a Manufacturing Engineering leader to drive NPI and design transfer for complex electromechanical medical devices. You will coordinate pilot builds, define cell layouts, and ensure readiness of tooling, documentation, and processes for full production.

Successful candidates will have a strong track record in FDA QSR and ISO 13485 environments, plus proven ability to lead cross-functional teams and deliver high-quality documentation and results.