Manager, Instrument NPI Engineering (P-4819) at 10x Genomics

Singapore, , Singapore -

Full Time

Start Date

Immediate

Expiry Date

22 Jan, 26

Salary

0.0

Posted On

24 Oct, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Manufacturing Engineering, Process Engineering, Design for Manufacturing, Design for Assembly, Project Management, Quality Control, Statistical Process Control, NPI Support, Mechanical Engineering, Electrical Engineering, ISO 9001, ISO 13485, Good Documentation Practices, Good Manufacturing Practices, Supplier Readiness Assessment, Lean Six Sigma

Industry

Biotechnology Research

Description

We are seeking a Manager to join the instrument New Product Introduction (NPI) EngineeringTeam. This person will be responsible for the design transfer and scale-up of new instrument platforms, establishing and validating manufacturing processes, equipment/fixture/tooling design and qualification, and ensuring manufacturability, optimized to deliver high-quality products from pilot build through mass production. The ideal candidate will have a strong background in manufacturing and process engineering, with a proven track record of successfully launching complex capital equipment. Knowledge and hands-on experience with Design for Manufacturing (DFM) and Design for Assembly (DFA), managing contract manufacturing partners during product launch, and transitioning products from R&D to full production are required. What you will be doing: Lead team of engineers in the design transfer and creation of robust manufacturing processes, including validation and Gage R&R studies, and initial equipment qualifications. Implement both talent management and project management tools to successfully manage resources and monitor NPI phase-gate milestones. Review and approve, draft when necessary, process documentation, including transfer protocols and initial build reports. Engage with R&D/Design Engineering, contract manufacturers, and internal quality, to drive new product manufacturability reviews, resolve critical build issues, and ensure process stability before full launch, with a focus on meeting initial Cost of Goods Sold (COGs) targets. Interfaces with design engineering and Product Management to coordinate the release of initial ECOs for both hardware and software, focusing on product configuration and BOM maturity. Work with design engineering to optimize product design for high-volume manufacturing, driving DFM/DFA principles. Create, perform, and lead the team in the execution of pilot and verification builds to identify and mitigate manufacturing risks. 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. Define, measure, and report first-pass yield and critical to quality (CTQ) metrics during the NPI phase. Identify and implement manufacturing solutions based on knowledge of new assembly methods, quality control standards, fabrication processes, tooling, production equipment, product design, and materials. Where needed implement early process controls, SPC (Statistical Process Control), to ensure quality product 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. Minimum Requirements: Bachelor’s degree, MS, or PhD in Engineering: Mechanical, Electrical, or Manufacturing with 5 years of relevant experience. 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. Preferred Qualifications: 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. 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.

Responsibilities

The Manager will lead a team in the design transfer and creation of robust manufacturing processes, ensuring manufacturability and quality from pilot builds through mass production. Responsibilities include engaging with R&D, managing contract manufacturers, and driving product manufacturability reviews.