Sr. NPI Manufacturing Engineer

ACE Partners; Minnesota; On-site; USD 110,000 - 170,000; Full time

Job summary

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.

Qualifications

• 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.

Responsibilities

• 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.

Skills

Technical writing

Cross-functional leadership

Independent work

Education

Bachelor's degree in Engineering

Master's degree in STEM

Tools

Microsoft Office

Job description

• Lead new product introduction and design transfer for complex electromechanical medical devices, from initial design reviews through production release
• Plan and run pilot builds, defining production cell layout, staffing, and equipment needs ahead of full-scale production
• Provide DFM/DFA feedback to development engineering and lead production readiness reviews to confirm processes, tooling, and documentation are qualified before ramp
• Coordinate with Production, Quality, and Supply Chain to plan and manage the ramp into full production volume, tracking open issues to closure
• Create and maintain production documentation, including build documentation, assembly and test procedures, part drawings, and engineering change orders
• Manage production builds across multiple product lines, maintaining the issues list and driving device improvements
• Represent Manufacturing on cross-functional NPI core teams, flagging risks to timelines and device cost
• Work with Quality Engineering to troubleshoot and resolve issues on the line
• Work directly with customers on technical requests, and coach and mentor the wider manufacturing engineering team

What we're looking for:

• Bachelor's degree in engineering, technical, or a scientific discipline, with a Master's in a STEM field a plus
• 6+ years of manufacturing engineering experience in an electronic-based manufacturing environment
• Demonstrated experience leading NPI or design transfer for complex electromechanical devices
• Experience in regulated environments, including FDA QSR and ISO 13485 for medical devices
• Proficiency with quality improvement tools and techniques
• Strong technical writing skills and proficiency in Microsoft Office
• Ability to work independently and to lead and drive cross-functional teams
• Leadership experience in operations and DFM/DFA and production readiness review experience a plus