Manager, Instrument NPI Engineering (P-4819)

Implement both talent management and project management tools to successfully manage resources and monitor NPI phase-gate milestones. Work with design engineering to optimize product design for high-volume manufacturing, driving DFM/DFA principles. Design and development of initial manufacturing test fixtures as required for first-pass quality control. Design fixtures and tooling to support efficient line setup and process control at launch. Investigate or resolve pre-production operational problems, such as initial material variances and line bottlenecks. Prepare reports and presentations summarizing information or trends related to NPI build performance and readiness for transfer. Provide technical expertise or support related to the initial manufacturing footprint and line design. Bachelor's degree, MS, or PhD in Engineering: Mechanical, Electrical, or Manufacturing with 5 years of relevant experience, including demonstrated experience in leading and managing technical teams. Work history with several successful iterations of NPI and design transfer into high-volume manufacturing. Ability to review and update mechanical drawings, ability to read schematics. Creation of Design for Manufacturing (DFM) reports, pFMEAs, initial ECOs, work instructions, and qualification documentation. Experienced in Supplier Readiness Assessment and NPI 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 NPI and instrument manufacturing under ISO 9001 or ISO 13485 standards. Expertise in cGDP (Good Documentation Practices) and cGMP (Good Manufacturing Practices). Ability to travel to contract manufacturers (approximately 5%) for product launch support. Desire to be part of a rapidly evolving organization, with a compelling technology, and establishing robust processes for the next generation of products. Strong experience managing technical teams and fostering their professional growth. Experience with SolidWorks, Oracle, Arena is a plus. Lean Six Sigma Green/Black Belt Certification. Direct experience with volume ramp-up and production line commissioning.