NPI Manager

ENvue Med; Minnesota; On-site; USD 90,000 - 120,000; Full time

Job summary

A progressive medical technology company is seeking an NPI Manager to oversee the product development lifecycle from design to production. The ideal candidate will have a Bachelor’s degree in Engineering and 4–7 years of experience in medical device launches. This role demands strong project management skills and a proactive approach to quality assurance. Join us to lead the development of next-generation bedside technology in a collaborative environment.

Qualifications

• 4–7 years of NPI or product launch experience in medical devices.
• Experience with ISO 13485/FDA quality systems.
• Detail-oriented and execution-focused.

Responsibilities

• Own the full NPI lifecycle from design freeze through pilot builds.
• Develop and maintain phase gate schedules, project plans, and risk logs.
• Lead design transfer activities including BOMs and test procedures.
• Coordinate DFM/DFT reviews and manage production builds.
• Support quality activities including PFMEA and IQ/OQ/PQ documentation.

Skills

NPI lifecycle management

Project planning

Risk management

Quality assurance

Cross-team coordination

Education

Bachelor’s degree in Engineering or Industrial Engineering

Job description

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.