Head of Hardware Engineering — Medical Device Systems Lead

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

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.