Head of Hardware Engineering

Revalia Bio, Inc.; United States; Hybrid; USD 190,000 - 240,000; Full time

Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

Retirement plan

Job summary

Revalia Bio, Inc. is seeking a Head of Hardware to own the Orpheus perfusion system, overseeing design, engineering, manufacturing and assembly.

You will grow a team of engineers and external partners, set priorities, and guide hardware across live studies, ensuring data quality and reliability for medical testing. The role reports to the CEO and requires hands-on leadership, with base in-person work in New Haven, CT or Indianapolis, IN, plus travel for occasional remote work.

Qualifications

• Degree in mechanical engineering, biomedical engineering or a similar technical field.
• 7+ years designing and building complex electromechanical or fluidic systems, ideally in lab automation or medical device manufacturing.
• 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.

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.

Skills

Team leadership

Mentoring

Project management

Design for manufacturability

Education

Bachelor's in Mechanical or Biomedical Engineering

Job description

The role

Our Head of Hardware will own Orpheus, the perfusion system behind every study we run. It combines custom hardware, sensors and design with third-party parts, and has been refined over years for medicine testing. Custom components include organ containers, cannulas, sensors, reservoirs and mixing, and pressure and flow regulators.

You will lead design, engineering, manufacturing and assembly, and grow the fleet to keep pace with demand. You will manage a small team of engineers plus external contractors and design firms, mentor and develop them over time, and join the leadership team.

• Reports to: CEO
• Location: In person in New Haven, CT or Indianapolis, IN; remote candidates considered if willing to travel regularly

What you’ll do

• 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.

What you bring

• A degree in mechanical engineering, biomedical engineering or a similar technical field.
• 7+ years designing and building complex electromechanical or fluidic systems, ideally in lab automation or medical device manufacturing.
• 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.

Nice to have

• 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.

Location, travel and compensation

This is a hands-on role that works best in person with the team and the lab, and we expect you to be based in New Haven, CT or Indianapolis, IN. We will consider remote candidates willing to travel regularly. Expected base salary is 190,000 to 240,000 USD plus meaningful equity and bonus, with competitive benefits (health, dental, vision, retirement, disability, wellness stipend) from day one.

We look for people who live our values: world-class collaboration, cultivating deep trust, relentless adaptability, and persevering with uncommon grit.

Revalia Bio acknowledges and celebrates the diversity of our workforce, is dedicated to creating an equitable workplace, and aims to create a culture where every individual feels a sense of belonging. We are an equal opportunity employer and do not discriminate on the basis of race, religion, color, national origin, sex, sexual orientation, gender, gender identity or expression, age, disability, or genetic makeup. To request accommodations, please email [e-mail].

Revalia Bio is an equal opportunity employer.