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. About 10x Genomics At 10x Genomics, accelerating our understanding of biology is more than a mission for us. It is a commitment. This is the century of biology, and the breakthroughs we make now have the potential to change the world. We enable scientists to advance their research, allowing them to address scientific questions they did not even know they could ask. Our tools have enabled fundamental discoveries across