Tech Stack

Description

You will lead New Product Introduction activities for capital equipment and disposable medical devices, ensuring products are manufacturable, scalable, and compliant. You'll drive manufacturing readiness, collaborate with cross-functional teams, and oversee process validation and production ramp-up.

Requirements

• B.S. in Industrial, Mechanical, Manufacturing Engineering or related field
• 7+ years medical device manufacturing and NPI experience with disposables
• Advanced English
• Previous supervisory or team-lead experience
• Strong knowledge of FDA QSR, GMP, ISO 13485

Responsibilities

• Lead and supervise NPI/Manufacturing Engineers
• Own manufacturing readiness for NPI programs from concept through production ramp
• Serve as primary manufacturing interface to R&D, driving DFM/DFA and cost optimization
• Develop and scale manufacturing processes, tooling, fixtures, equipment, and test methods
• Lead process validation (IQ/OQ/PQ, MSA) in compliance with FDA QSR, GMP, ISO 13485