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Staff Mechanical Engineer, Consumables at 10x Genomics

Pleasanton, California, United States -

Full Time

Start Date

Immediate

Expiry Date

11 May, 26

Salary

0.0

Posted On

10 Feb, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Injection Molding, Over-molding, LSR, Ultrasonic Welding, Laser Bonding, Microfluidics, FEA, Tolerance Analysis, CFD, ISO 13485, FDA 21 CFR Part 820, Design History File (DHF), Mentorship, SolidWorks, Creo, FMEA

Industry

Biotechnology Research

Description

High-Precision Consumables: Lead the architecture and design of complex biotech consumables, focusing on Injection Molded (IM) plastics, over-molding, LSR and assembly techniques (ultrasonic welding, laser bonding). Fluidic Integration: Drive the development of fluidic and microfluidic systems by consulting with fluidic SMEs, ensuring seamless integration between consumable cartridges and permanent instrument hardware. Advanced Simulation: Utilize FEA, tolerance analysis, and CFD to predict part behavior and ensure robust performance under laboratory operating conditions. Regulatory Excellence: Design for compliance with ISO 13485, FDA 21 CFR Part 820 as well as RUO. Contribute to the creation of Design History Files (DHF). Technical Mentorship: Directly mentor junior Engineers, fostering a culture of rigorous engineering discipline and creative problem-solving. Cross-Functional Bridge: Serve as the "mechanical voice" in rooms full of Biologists, Chemists, and Software Engineers to ensure the hardware meets the underlying science. Education: BS/MS in Mechanical Engineering. Experience: 10+ years of experience in mechanical design, with at least 5 years specifically in medical devices or biotech consumables. Plastics Expertise: Deep knowledge of thermoplastic resins (COC, COP, PC, PP), elastomers (TPE/TPU), and the nuances of high-volume injection molding. Tooling/Equipment: Experience with CAD (SolidWorks/Creo), PDM systems, and simulation suites. Quality Systems: Familiarity with Risk Management (ISO 14971), FMEA, and Gage R&R.

Responsibilities

This role involves leading the architecture and design of complex biotech consumables, primarily focusing on injection-molded plastics, over-molding, and assembly techniques while ensuring seamless fluidic integration with instrument hardware. The engineer will also utilize advanced simulation tools and mentor junior staff, acting as the mechanical representative in cross-functional teams.