Senior NPI Engineer (P-4823)

We are seeking a Senior NPI Engineer to join the Instrument Manufacturing Engineering Team. This person will be responsible for the development and implementation of manufacturing process improvements, equipment/fixture/tooling design and qualification, process development and qualification, optimized to deliver high quality products and meet production demand.

Requirements

• Bachelor’s degree in Engineering: Mechanical, Electrical or Manufacturing with 5+ years of experience, or MS/ PhD with 4-5 years of experience.
• Work history of qualifying multiple manufacturing processes.
• Ability to review mechanical drawings, ability to read schematics
• Creation of pFMEAs, ECOs, work instructions, and qualification documentation.
• Experienced in Supplier Engagement and support, domestic and offshore
• Working knowledge of, but not limited to, manufacturing and assembly techniques, machining, injection molding, instrument and consumables for biotech
• Experience working with instrument manufacturing under ISO 9001 or ISO 13485 standards.
• Expertise in cGDP, cGMP.