Manufacturing NPI Engineer II

About the role

The Manufacturing NPI Engineer II will lead the development, transfer, and scale‑up of complex medical device manufacturing processes, focusing on catheters, delivery systems, and implantable assemblies. You will work closely with customers and cross‑functional teams to create robust, compliant processes from prototype through commercial production.

Key responsibilities

• Support new‑product‑introduction (NPI) and manufacturing process development for catheters, delivery systems, and implantable devices.
• Collaborate with cross‑functional teams to evaluate manufacturability, risk, and scalability.
• Assist with process transfer, validation (IQ/OQ/PQ), and production scale‑up.
• Define manufacturing methods, tooling, and process flows, supporting Design for Manufacturing (DFM) activities.
• Develop and maintain manufacturing documentation such as work instructions, bills of materials, specifications, and routing sheets.
• Ensure compliance with FDA regulations, ISO 13485, and GMP standards.
• Provide technical support, troubleshoot issues, and drive continuous improvement in quality and yield.

Required profile

• Bachelor’s degree in Mechanical, Biomedical, Manufacturing, Materials Engineering, or a related technical field.
• 3–4 years of experience in medical device manufacturing or NPI engineering.
• Hands‑on experience with high‑precision assembly under magnification.
• Experience working in ISO 13485 and FDA‑regulated environments.
• Preferred experience with catheter, delivery system, or implantable device manufacturing.

Required skills

• Process development and transfer
• Validation (IQ/OQ/PQ)
• Design for Manufacturing (DFM)
• Manufacturing documentation (work instructions, BOMs, specs, routers)
• Regulatory compliance (FDA, ISO 13485, GMP)
• High‑precision assembly under magnification