Principal Mechanical Engineer (Medical Devices)

Location: On-site in San Diego, California, United States

Salary: $165,000–$200,000 annually, depending on experience and qualifications.

Company

hirify.global is an early-stage biotechnology company developing genomics and molecular detection platforms that integrate molecular biology, chemistry, and systems engineering.

What you will do

• Own the mechanical and electromechanical architecture of a point-of-care molecular diagnostic instrument from concept through launch and sustaining support.
• Translate assay, biological, and user requirements into system architectures and subsystem specifications for fluidics-based instrumentation.
• Design and integrate fluidic, motion, actuation, thermal, optical, mechatronic, and electrical systems.
• Develop custom consumables and disposable cartridges, including fluidic routing, valving, sealing, registration, and alignment mechanisms.
• Build breadboard systems, functional prototypes, and reliability test stations, while defining and supporting system-level verification testing.
• Direct outsourced design partners, CDMOs, and technology vendors, and support DFM, DFA, pilot builds, design transfer, and manufacturing.

Requirements

• Proven experience designing reliable electromechanical, fluidic, optical, and thermal systems through the full product development lifecycle.
• Experience with fluidically driven systems, preferably microfluidic applications in life science, molecular diagnostics, or point-of-care products.
• Experience designing custom consumables and registration and alignment mechanisms.
• Fluency in SolidWorks CAD, GD&T, and tolerance stack-up analysis.
• Understanding of manufacturing processes including injection molding, machining, joining, and automated assembly.
• Ability to work as a hands-on individual contributor, direct vendors and outsourced partners, and collaborate across biology, assay development, software, and manufacturing.

Nice to have

• Experience with FEA and CFD for thermal, fluid, and structural analysis.
• Medical device or in vitro diagnostic development under FDA design controls and ISO 13485, or familiarity with cGMP manufacturing.
• Experience with PCR or isothermal amplification instruments, automated sample preparation, pilot production, design transfer, or manufacturing workflows.
• Experience mentoring engineers or establishing an internal engineering function.

Culture & Benefits

• Collaborative, cross-functional, R&D-driven environment.
• Opportunity to shape foundational hardware capabilities and technical direction at an early-stage company.
• Medical, dental, and vision coverage.
• Company-paid life insurance and a 401(k) retirement plan.
• Paid time off, voluntary benefits, employee perks, and discount programs.