Head of Hardware Engineering

Revalia Bio

. Own the Orpheus roadmap across design, engineering, manufacturing and assembly, from component upgrades to full design revisions .

Posted 10/20/2026full-timeNew Haven • Connecticut • United StatesLead💰 $190,000 - $240,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in designing and building complex electromechanical systems, with a strong focus on quality management systems and regulatory compliance. Proven leadership in managing engineering teams and contractors while driving innovation in lab automation and medical device manufacturing.

Highest-signal resume keywords

Mechanical Engineering Degree7+ Years Designing Electromechanical SystemsQuality System ExperienceTeam Management and MentoringFamiliarity with GLP and GMP

ATS Keywords

Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills

Design ControlsChange ControlDocumentation and TraceabilityPrototype DevelopmentManufacturing and Assembly

Soft Skills

LeadershipMentoringTeam BuildingCommunication

Tools & Technologies

Contract ManufacturersDesign FirmsSensorsPumpsFlow Control

Industry Keywords

Good Laboratory PracticeISO 1348521 CFR Part 11PerfusionBioreactors

Tech Stack

Tools & technologies

Assembly

About the role

Key responsibilities & impact

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 the team and build the hiring plan as the fleet grows
Support the 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
Report to the CEO
Join the leadership team

Requirements

What you’ll need

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
Remote candidates must be willing to travel regularly
Nice to have: Familiarity with GLP, GMP, ISO 13485 or 21 CFR Part 11 environments
Nice to have: Experience with perfusion, bioreactors, blood-contacting or sterile-fluid-path devices
Nice to have: Experience with sensors, pumps and flow or pressure control
Nice to have: Experience with sterilization, biocompatibility or cleaning validation
Nice to have: Experience scaling a fleet of instruments across multiple sites

Benefits

Comp & perks

Meaningful equity
Bonus
Health insurance
Dental insurance
Vision insurance
Retirement benefits
Disability benefits
Wellness stipend
Competitive benefits from day one