Staff Mechanical Engineer, Consumables
About The Position
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.
Requirements
- BS/MS in Mechanical Engineering
- 10+ years of experience in mechanical design, with 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
Responsibilities
- Lead the architecture and design of complex biotech consumables
- Drive the development of fluidic and microfluidic systems
- Utilize FEA, tolerance analysis, and CFD to predict part behavior
- Design for compliance with ISO 13485, FDA 21 CFR Part 820 as well as RUO
- Contribute to the creation of Design History Files (DHF)
- Directly mentor junior Engineers
- Serve as the "mechanical voice" in rooms full of Biologists, Chemists, and Software Engineers
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
