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NPI Manager

Job in Duluth, St. Louis County, Minnesota, 55806, USA
Listing for: ENvue Med
Full Time position
Listed on 2026-03-04
Job specializations:
  • Engineering
    Quality Engineering
Salary/Wage Range or Industry Benchmark: 80000 - 100000 USD Yearly USD 80000.00 100000.00 YEAR
Job Description & How to Apply Below

We’re always looking for talented
people to join our team!

ABOUT

THE ROLE
NPI Manager

We are seeking a software QA engineer to validate ENvue software releases, ensuring stability and compliance.

  • Own the full NPI lifecycle from design freeze through pilot builds, verification, and production ramp.
  • Develop and maintain phase gate schedules, project plans, and risk logs.
  • Lead design transfer activities including BOMs, work instructions, and test procedures.
  • Coordinate DFM/DFT reviews and manage prototype and pilot production builds.
  • Support quality activities including PFMEA, control plans, and IQ/OQ/PQ documentation.
Qualifications
  • Bachelor’s degree in Engineering or Industrial Engineering.
  • 4–7 years of NPI or product launch experience in medical devices.
Preferred Experience

Capital equipment development, ISO 13485/FDA quality systems, and multi-site team coordination.

Personal Attributes

Detail-oriented, execution-focused, and skilled at driving alignment across distributed teams.

Why Join Us

Own the process that brings ENvue’s next generation of bedside technology to life.

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