Head of Hardware Engineering

Revalia Bio is hiring a Head of Hardware Engineering to own the Orpheus perfusion system and lead its design, engineering, manufacturing, assembly, and fleet growth. The role manages engineers, technicians, and external partners while improving system reliability, data quality, and production capacity.

Responsibilities:

• Own the Orpheus roadmap across design, engineering, manufacturing and assembly, from component upgrades to full design revisions
• Lead new design revisions that cut manual effort in running a perfusion and raise data quality, reliability and repeatability
• Scale the fleet to meet pharma demand, including build plans, supply chain, sterilization and service capacity for new perfusion centers starting in 2027
• Direct the design and sourcing of custom components, including organ containers, cannulas, sensors, reservoirs, mixing, and pressure and flow regulators
• Manage a small team of engineers and technicians plus external contractors and design firms; set priorities, review work and hold vendors to schedule and quality
• Mentor and develop your team and build the hiring plan as the fleet grows
• Support our quality management system so that design, build, change control, calibration and maintenance records meet Good Laboratory Practice (GLP) expectations for data that supports IND filings
• Work with science, software, quality and operations to turn perfusion lessons into hardware improvements

Requirements:

• A degree in mechanical engineering, biomedical engineering or a similar technical field
• 7+ years designing and building complex electromechanical or fluidic systems
• 2+ years managing engineers, or leading teams and contractors, with a track record of mentoring and growing people
• Experience taking designs from prototype through repeatable, documented manufacturing and assembly
• Experience working within a quality system: design controls, change control, documentation and traceability
• Experience managing contract manufacturers, design firms and suppliers
• Comfort in a fast-growing startup, where you set direction, build the process and still pick up a tool when needed
• ideally in lab automation or medical device manufacturing
• Familiarity with GLP, GMP, ISO 13485 or 21 CFR Part 11 environments
• Experience with perfusion, bioreactors, blood-contacting or sterile-fluid-path devices
• Experience with sensors, pumps and flow or pressure control
• Experience with sterilization, biocompatibility or cleaning validation
• Experience scaling a fleet of instruments across multiple sites