Senior NPI Mechanical Engineer (P-4823)

We are seeking a Senior NPI Mechanical 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.

The ideal candidate will have a strong background in NPI, mechanical design, manufacturing and process engineering. This role requires strong mechanical engineering fundamentals, a collaborative mindset, and the ability to work effectively across functional teams including manufacturing, service, operations, and quality.

What you will be doing:

• Lead and support mechanical engineering efforts for NPI, covering design development, verification, validation, and production transfer.
• Design and development of manufacturing test fixtures as required. Design fixtures and tooling to help reduce cost of machine setup and reduce scrap
• Teaming with R&D, QA and Production departments to design, develop, test, document and implement processes, tooling, and fixtures.
• Lead effort to develop and maintain process Failure Modes and Effects Analyses (pFMEAs) for company processes, implement mitigations, and leverage risk based decision making.
• Create process requirements for both informing design activities, and to implement equipment and fixturing needed for process development and manufacturing efforts.
• 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.
• Using Lean principles, Lead and/or actively participate in product/process engineering problem solving.
• Identify opportunities and implement changes to improve products and reduce costs by using knowledge of assembly methods, quality control standards, fabrication processes, tooling, production equipment, product design, and materials
• 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.

Minimum Requirements:

• Bachelor’s degree in Engineering: Mechanical, with 5 years of experience, or MS/ PhD with 4 years of experience.
• Strong background in mechanical design for complex capital equipment, ideally including optics, motion systems, and fluidics.
• Ability to review mechanical drawings, ability to read schematics
• Proficient in SolidWorks for 3D CAD modeling, design analysis, and creating detailed mechanical drawings.
• Creation of pFMEAs, ECOs, work instructions, and qualification documentation.
• 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.

Preferred Qualifications:

• Experience with DFM/DFT/DFA and process validation in regulated environments (e.g., ISO 13485, FDA).
• Comfortable managing BOMs, ECOs, and documentation in a structured product development environment.