Staff NPI Engineer
Description For Staff NPI Engineer
10x Genomics is seeking a Staff NPI Engineer to join their Instrument Manufacturing Engineering Team in Singapore. This pivotal role involves creating and leading the NPI team, establishing governance for supplier management, and overseeing engineering project management. The position combines technical expertise with leadership responsibilities in a cutting-edge biotechnology environment.
The role demands a strong background in New Product Introduction (NPI), manufacturing, and process engineering, with hands-on experience in contract manufacturing and internal production assembly. The successful candidate will be instrumental in developing and implementing manufacturing process improvements, designing equipment and tooling, and ensuring high-quality product delivery.
Key responsibilities include collaboration with R&D and QA departments, process development and qualification, and implementation of quality control measures. The position requires expertise in creating process FMEAs, developing documentation, and utilizing Lean principles for problem-solving. The ideal candidate will have at least 7 years of experience with a Bachelor's degree or 5 years with an advanced degree in relevant engineering fields.
10x Genomics is at the forefront of biological research, enabling scientists to make groundbreaking discoveries in cancer, immunology, and neuroscience. The company offers an inclusive and dynamic environment where innovation is encouraged and individual contributions are valued. This role presents an opportunity to be part of a rapidly evolving organization with compelling technology, helping to advance the field of biotechnology and contribute to significant scientific breakthroughs.
The position offers the chance to work with cutting-edge technology while developing and implementing manufacturing processes that will directly impact the production of innovative scientific instruments. The role combines technical expertise, leadership, and strategic thinking, making it an excellent opportunity for an experienced engineer looking to make a significant impact in the biotechnology industry.
Responsibilities For Staff NPI Engineer
- Team with R&D, QA and Production departments to design, develop, test, document and implement processes, tooling, and fixtures
- Define, measure and report key metrics for production quality and cost
- Lead effort to develop and maintain process Failure Modes and Effects Analyses (pFMEAs)
- Create process requirements for design activities and implement equipment
- Develop and maintain documentation for design and process control
- Evaluate and implement process improvements
- Design and development of manufacturing test fixtures
- Lead product/process engineering problem solving using Lean principles
- Support product line transfers and qualification-validation efforts
- Provide technical expertise related to manufacturing
Requirements For Staff NPI Engineer
- Bachelor's degree in Engineering (Mechanical, Electrical or Manufacturing) with 7 years of experience, or MS/PhD with 5 years of experience
- Experience in qualifying multiple manufacturing processes
- Ability to review mechanical drawings and read schematics
- Experience in creating pFMEAs, ECOs, work instructions, and qualification documentation
- Experience in Supplier Engagement and support, domestic and offshore
- Knowledge of manufacturing and assembly techniques, machining, injection molding
- Experience with instrument manufacturing under ISO 13485 standards
- Expertise in cGDP, cGMP
- Ability to travel to contract manufacturers (10%)
- Experience with SolidWorks, Oracle, Arena (preferred)
- Lean Six Sigma Green/Black Belt Certification (preferred)
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