Senior NPI Engineer (P-4823)

Develop and maintain documentation for design and process control, product configurations, manufacturing procedures, (e.g., travelers, bills-of-materials, Work Instructions, Lot History Records), and other Quality System requirements. Evaluate existing engineering processes and implement process improvements. Design and development of manufacturing test fixtures as required. Design fixtures and tooling to help reduce cost of machine setup and reduce scrap Support the transfer of product lines and the qualification-validation efforts Prepare reports and presentations summarizing information or trends related to manufacturing performance Provide technical expertise or support related to manufacturing. 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. Ability to travel to contract manufacturers (approximately 10%) Desire to be part of a rapidly evolving organization, with a compelling technology, and taking products and processes to the next level. Experience with SolidWorks, Oracle, Arena is a plus. Lean Six Sigma Green/Black Belt Certification.