Senior NPI Mechanical Engineer

10X Genomics; Singapore; On-site; SGD 70,000 - 100,000; Full time

Job summary

A leading biotech organization in Singapore is seeking a Senior NPI Mechanical Engineer. This position involves developing and implementing manufacturing process improvements, designing tools and fixtures, and collaborating with various teams. The ideal candidate will have a solid background in mechanical design, NPI, and process engineering, along with experience in regulated environments. This role promises a dynamic work environment and opportunities for professional growth.

Qualifications

• 5 years of experience in mechanical design, manufacturing, and process engineering.
• Proficient in SolidWorks for CAD modeling and design analysis.
• Experience working under ISO 9001 or ISO 13485 standards.

Responsibilities

• Lead mechanical engineering efforts for NPI.
• Design manufacturing test fixtures to reduce costs.
• Develop and maintain documentation for design and process control.

Skills

Mechanical design

NPI

Process engineering

SolidWorks

Lean principles

Education

Bachelor’s degree in Mechanical Engineering

MS/PhD in Engineering

Tools

SolidWorks

Lean manufacturing tools

Job description

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.
• 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 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.