Tech Stack

Description

You will serve as the primary technical architect for next-generation biotech platforms, leading the design of high-precision consumables and fluidic systems from concept through high-volume manufacturing. Your work will bridge instrument hardware and consumables, ensuring scalability, regulatory compliance, and innovation.

Requirements

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

Responsibilities

• Lead architecture and design of complex biotech consumables (injection molded plastics, over-molding, LSR, assembly techniques).
• Drive development of fluidic and microfluidic systems, ensuring integration with instrument hardware.
• Utilize FEA, tolerance analysis, and CFD for robust design.
• Design for compliance with ISO 13485, FDA 21 CFR Part 820, and RUO; contribute to Design History Files.
• Own critical subsystems from concept to high-volume manufacturing.
• Champion Design for Manufacturing (DFM) and Design for Assembly (DFA).
• Act as primary technical contact for external molding partners and material suppliers.
• Identify and pursue patentable innovations in fluid handling, sealing, and consumable-to-instrument interfaces.
• Lead root cause analysis for plastic component failures.
• Mentor junior engineers and serve as mechanical voice in cross-functional teams.