We are seeking a Senior NPI 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, manufacturing and process engineering. Knowledge and hands on experience with contract manufacturing, internal production assembly, calibration and control for instrument or capital equipment manufacturing.
What you will be doing:
- Teaming 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. Collect data and analyze process performance and capabilities for internal manufacturing operations.
- Lead effort to develop and maintain process Failure Modes and Effects Analyses (pFMEAs) for company processes, implement mitigations, and leverage risked 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.
- Design and development of manufacturing test fixtures as required. Design fixtures and tooling to help reduce cost of machine setup and reduce scrap
- 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, 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 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 SolidWorks, Oracle, Arena is a plus.
- Lean Six Sigma Green/Black Belt Certification
#LI-ES1 #LI-onsite #npiengineers
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 biology including cancer, immunology, and neuroscience.
Our teams are empowered and encouraged to follow their passions, pursue new ideas, and perform at their best in an inclusive and dynamic environment. We know that behind every scientific breakthrough, there is a deep infrastructure of talented people driving the life sciences industry and making it possible for scientists and clinicians to make new strides. We are dedicated to finding the very best person for every aspect of our work because the innovations and discoveries that we enable together will lead to better technologies, better treatments, and a better future. Find out how you can make a 10x difference.
Individuals seeking employment at 10x Genomics are considered without regards to race, color, religion, national origin, age, sex, marital status, ancestry, physical or mental disability, veteran status, gender identity, or sexual orientation, or any other characteristic protected by applicable law.
10x does not accept unsolicited applicants submitted by third-party recruiters or agencies. Any resume or application submitted to 10x without a vendor agreement in place will be considered unsolicited and property of 10x, and 10x will not pay a placement fee.
