Staff Mechanical Engineer, Consumables

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.