Head of Hardware Engineering

Revalia Bio•New Haven, CT

12h•$190,000 - $240,000

About The Position

The Head of Hardware Engineering will own Orpheus, Revalia Bio’s perfusion system used in every study. The system combines custom hardware and sensors with third-party components and has been refined over years for medicine testing. Custom components include organ containers, cannulas, sensors, reservoirs and mixing, and pressure and flow regulators. This hands-on leadership role oversees Orpheus design, engineering, manufacturing and assembly, and scales the instrument fleet to meet demand. The role manages and develops a small team of engineers and technicians, as well as external contractors and design firms, and participates in the leadership team. The position is expected to be based in person in New Haven, Connecticut, or Indianapolis, Indiana; remote candidates may be considered if willing to travel regularly. The Head of Hardware Engineering will guide the system roadmap, lead design revisions that reduce manual work and improve data quality and reliability, and plan fleet growth, supply chain, sterilization and service capacity for new perfusion centers starting in 2027. The role also supports the quality management system and works across science, software, quality and operations to translate perfusion experience into hardware improvements. Expected base salary is $190,000–$240,000, plus meaningful equity and bonus. Competitive benefits are available from day one. Revalia Bio emphasizes collaboration, trust, adaptability and perseverance, and is an equal opportunity employer committed to an equitable workplace and belonging.

Requirements

Degree in mechanical engineering, biomedical engineering or a similar technical field.
At least 7 years designing and building complex electromechanical or fluidic systems; lab automation or medical device manufacturing experience is preferred.
At least 2 years managing engineers or leading teams and contractors, with a track record of mentoring and developing people.
Experience taking designs from prototype through repeatable, documented manufacturing and assembly.
Experience working within a quality system, including design controls, change control, documentation and traceability.
Experience managing contract manufacturers, design firms and suppliers.
Comfort working in a fast-growing startup, setting direction and building processes while also performing hands-on work when needed.

Nice To Haves

Familiarity with GLP, GMP, ISO 13485 or 21 CFR Part 11 environments.
Experience with perfusion, bioreactors, blood-contacting devices 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.

Responsibilities

Own the Orpheus roadmap across design, engineering, manufacturing and assembly, from component upgrades through full design revisions.
Lead design revisions that reduce manual effort in running a perfusion and improve data quality, reliability and repeatability.
Scale the fleet to meet pharmaceutical 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, along with external contractors and design firms; set priorities, review work, and hold vendors to schedule and quality expectations.
Mentor and develop the team and build the hiring plan as the fleet grows.
Support the quality management system so design, build, change control, calibration and maintenance records meet Good Laboratory Practice expectations for data supporting IND filings.
Collaborate with science, software, quality and operations to turn perfusion lessons into hardware improvements.