Staff Mechanical Engineer, Consumables

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.

What you will be doing

1. Strategic Design & Technical Leadership

• 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).

2. End-to-End Project Ownership

• Concept to production: Take full ownership of critical subsystems from "napkin sketch" through high-volume manufacturing (HVM).
• DFX Leadership: Champion Design for Manufacturing (DFM) and Design for Assembly (DFA), working closely with toolmakers and CMOs to ensure tool designs and strategies are optimized.
• Vendor Management: Act as the primary technical point of contact for external molding partners and material suppliers, ensuring quality and performance standards are met.

3. Innovation & Problem Solving

• IP Generation: Identify and pursue patentable innovations in fluid handling, sealing technologies, and consumable-to-instrument interfaces.
• Root Cause Analysis: Lead complex failure analysis (FEA, SEM, etc.) for plastic components, identifying issues like creep, stress cracking, or biocompatibility failures and implementing permanent corrective actions.

4. Leadership & Mentorship

• 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.

Minimum Requirements

• 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.