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Key Responsibilities
• 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.