Head of Hardware Engineering

Sierra Ventures; United States; Hybride; USD 190 000 - 240 000; Plein temps

Avantages offerts par ce poste

Equity

Bonus

Health insurance

Dental insurance

Vision insurance

Retirement plan

Disability insurance

Wellness stipend

Résumé du poste

Revalia Bio seeks a Head of Hardware Engineering to own the Orpheus perfusion system used in our studies. You will lead design, engineering, manufacturing, and assembly, growing a small team of engineers and external partners, while reporting to the CEO.

You will drive revisions to cut manual effort, improve data quality, and scale the fleet to meet pharma demand. In-person work is preferred in New Haven, CT or Indianapolis, IN, with regular travel for remote candidates.

Qualifications

• Degree in mechanical or biomedical engineering.
• 7+ years designing and building complex electromechanical or fluidic systems.
• 2+ years leading engineers or contractors.
• Experience moving designs from prototype to repeatable manufacturing.
• Experience in quality systems: design controls, change control, documentation and traceability.

Responsabilités

• Own the Orpheus roadmap across design, engineering, manufacturing and assembly.
• Lead design revisions to reduce manual effort and improve data quality.
• Scale the fleet to meet pharma demand, including build plans and supply chain.
• Direct design and sourcing of custom components.
• Manage engineers and external contractors; set priorities and ensure schedule.
• Mentor your team and plan hiring as the fleet grows.
• Support GLP-compliant data records for IND filings.
• Collaborate with science, software, quality, and operations for hardware improvements.

Connaissances

Electromechanical design

People management

Prototype to manufacturing

Quality systems

Formation

Bachelors in mechanical or biomedical engineering

Outils

Contract manufacturers management

Supplier management

Description du poste

About Revalia Bio

Revalia is generating the human data that AI models of biology need. We keep donated, non-transplantable human organs functioning on our proprietary perfusion technology and measure how they behave and respond to medicines, producing data that is not available from other sources.

We are building this data to train AI models of human biology, with the aim of making drug discovery faster and less costly. Our perfusion data is already becoming part of biopharma programs built on new approach methodologies (NAMs), and it supports IND filings and decisions to begin human clinical trials.

A Yale spinout headquartered in New Haven, CT, we are backed by $20M in venture funding and $30M in government contracts, including an ARPA-H award. Demand from pharma is growing, and we plan to open additional perfusion centers starting in 2027.

The role

Our Head of Hardware Engineering 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 will 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.