This list contains only the countries for which job offers have been published in the selected language (e.g., in the French version, only job offers written in French are displayed, and in the English version, only those in English).
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