Staff Mechanical Engineer, Consumables
Core
Design and lead the architecture of complex biotech consumables (injection molded plastics, fluidic systems) for single-cell analysis instruments, ensuring integration with biological workflows and regulatory compliance.
Role type
Staff Mechanical Engineer (Medical Devices/Biotech Consumables)
Builds
High-volume injection molded plastic consumables, microfluidic cartridges, and fluidic integration systems for Atera and similar single-cell analysis platforms.
Domain
Life Sciences / Biotechnology / Medical Devices
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
High-volume injection molding design, thermoplastic resin expertise (COC, COP, PC, PP), fluidic and microfluidic system design, FEA/CFD simulation, Design for Manufacturing (DFM) and Assembly (DFA), regulatory compliance (ISO 13485, FDA 21 CFR Part 820), root cause analysis of plastic components, vendor management for tooling and materials.
Preferred skills
Patentable innovation in fluid handling/sealing, mentorship of junior engineers, cross-functional collaboration with biologists and chemists.
Technologies
SolidWorks, Creo, PDM systems, FEA/CFD suites, ultrasonic welding, laser bonding.
Responsibilities
Lead architecture and design of complex biotech consumables; drive development of fluidic and microfluidic systems; utilize FEA, tolerance analysis, and CFD to predict part behavior; design for compliance with ISO 13485 and FDA regulations; take full ownership of subsystems from concept to high-volume manufacturing; champion DFM/DFA and manage external molding partners; identify patentable innovations and lead complex failure analysis; mentor junior engineers and serve as the mechanical voice in cross-functional teams.
Seniority
Staff, technical leadership & mentorship