Head of Hardware Engineering

Revalia Bio•New Haven, CT

7d•Onsite

About The Position

The Head of Hardware Engineering owns Orpheus, Revalia Bio’s perfusion system used in its studies. Orpheus combines custom hardware and sensors with third-party components and has been refined over time for medicine testing. The role leads the system’s design, engineering, manufacturing, assembly, and fleet expansion to meet demand. It manages and develops a small team of engineers and technicians, along with external contractors and design firms, and is part of the leadership team. The position reports to the CEO. The role is hands-on and works best in person with the team and lab. The preferred locations are New Haven, Connecticut, or Indianapolis, Indiana; remote candidates may be considered if they are willing to travel regularly. The expected base salary is $190,000–$240,000, plus meaningful equity and a bonus. Competitive benefits are available from day one.

Requirements

Degree in mechanical engineering, biomedical engineering, or a similar technical field.
At least 7 years of experience designing and building complex electromechanical or fluidic systems; lab automation or medical device manufacturing experience is ideal.
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 remaining hands-on.

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 to complete design revisions.
Lead design revisions that reduce manual effort in perfusion and improve data quality, reliability, and repeatability.
Scale the system 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 systems, and pressure and flow regulators.
Manage a small team of engineers and technicians, 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.
Work with science, software, quality, and operations teams to turn perfusion lessons into hardware improvements.