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Staff Mechanical Engineer, Consumables

United States, Pleasanton 179300.00 - 242500.00 USD / Year · Job Posted February 10, 2026
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Job Description

As a Staff Mechanical Engineer, you will serve as a primary technical architect and design leader for our next generation of biotech platforms. You will bridge the gap between complex instrument hardware and high-volume biotech consumables. This role requires a deep technical expertise in plastics, fluidics, and consumables while steering cross-functional teams through the full product lifecycle. You are not just designing parts; you are defining and driving the technical strategy that ensures our products are scalable, regulatory-compliant, and revolutionary.

Job Responsibility

  • Strategic Design & Technical Leadership: 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)
  • Drive the development of fluidic and microfluidic systems by consulting with fluidic SMEs, ensuring seamless integration between consumable cartridges and permanent instrument hardware
  • Utilize FEA, tolerance analysis, and CFD to predict part behavior and ensure robust performance under laboratory operating conditions
  • Design for compliance with ISO 13485, FDA 21 CFR Part 820 as well as RUO. Contribute to the creation of Design History Files (DHF)
  • End-to-End Project Ownership: Take full ownership of critical subsystems from 'napkin sketch' through high-volume manufacturing (HVM)
  • Champion Design for Manufacturing (DFM) and Design for Assembly (DFA), working closely with toolmakers and CMOs to ensure tool designs and strategies are optimized
  • Act as the primary technical point of contact for external molding partners and material suppliers, ensuring quality and performance standards are met
  • Innovation & Problem Solving: Identify and pursue patentable innovations in fluid handling, sealing technologies, and consumable-to-instrument interfaces
  • Lead complex failure analysis (FEA, SEM, etc.) for plastic components, identifying issues like creep, stress cracking, or biocompatibility failures and implementing permanent corrective actions
  • Leadership & Mentorship: Directly mentor junior Engineers, fostering a culture of rigorous engineering discipline and creative problem-solving
  • Serve as the 'mechanical voice' in rooms full of Biologists, Chemists, and Software Engineers to ensure the hardware meets the underlying science

Requirements

  • BS/MS in Mechanical Engineering
  • 10+ years of experience in mechanical design
  • at least 5 years specifically in medical devices or biotech consumables
  • Deep knowledge of thermoplastic resins (COC, COP, PC, PP), elastomers (TPE/TPU), and the nuances of high-volume injection molding
  • Experience with CAD (SolidWorks/Creo), PDM systems, and simulation suites
  • Familiarity with Risk Management (ISO 14971), FMEA, and Gage R&R

What we offer

  • equity grants
  • comprehensive health and retirement benefit programs
  • annual bonus program or sales incentive program
  • generous time off
  • competitive and comprehensive health benefits package
  • easy-to-use benefits that promote wellbeing
  • family friendly policies like parental leave

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