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Senior NPI Mechanical Engineer (P-4823) at 10x Genomics

, , Singapore -

Full Time

Start Date

Immediate

Expiry Date

23 Apr, 26

Salary

0.0

Posted On

23 Jan, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Mechanical Design, Manufacturing Test Fixtures, Process Improvements, Documentation, SolidWorks, 3D CAD Modeling, DFM, DFT, DFA, ISO 9001, ISO 13485, cGDP, cGMP, ECOs, Qualification Documentation, Manufacturing Techniques

Industry

Biotechnology Research

Description

Design and development of manufacturing test fixtures as required. Design fixtures and tooling to help reduce cost of machine setup and reduce scrap 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. 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. 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.

Responsibilities

The Senior NPI Mechanical Engineer will be responsible for the design and development of manufacturing test fixtures and tooling to reduce costs and scrap. They will also evaluate existing engineering processes and implement improvements while supporting product line transfers and qualification efforts.