Hardware Engineer — Controller / Systems

About the role

The Hardware Engineer will bring additional engineering depth to the Gynesis platform during a critical stretch of the program. They will own controller and systems execution, partnering with an external electrical-design firm to drive design transfer and verification & validation (V&V) through design freeze and the FDA 510(k) submission. This role is essential for ensuring the program executes cleanly through this high-load phase.

Responsibilities

• Serve as Caldera's in-house owner of the Gynesis controller and systems engineering, partnering with external electrical-design firms to take the system to commercialization.
• Author and maintain engineering requirements, design inputs/outputs, and test protocols, keeping them traceable to the FDA 510(k) submission.
• Plan and execute verification & validation (V&V) — protocols, testing, and documented evidence — to demonstrate the device meets its requirements.
• Lead design transfer to the contract manufacturer, owning the supplier technical relationship and making the design production-ready.
• Cook up electrical interfaces across firmware, garment/electrode, and connector systems.
• Drive electrical-safety, EMC, and applicable consensus-standard compliance testing, coordinating external test labs as needed.
• Own engineering inputs and documentation in the Design History File (DHF) to audit-ready standards, and support design FMEAs/risk management with Quality.
• Provide hands-on engineering depth on a fast-moving, high-visibility program, directing external EE firms and contract manufacturers.
• Lead new hardware/systems development as additional indications and formats are pursued.

Requirements

• 7+ years of electrical/systems engineering experience in medical devices.
• Embedded/firmware fluency, with hands-on design-transfer and V&V experience.
• Comfort directing external EE firms and contract manufacturers.
• NMES/electrostimulation or wearable electronics experience is a strong plus.
• BSEE/BSECE or equivalent degree.

Qualifications

• Strong problem-solving skills and ability to work independently and as part of a team.
• Excellent communication and interpersonal skills.
• Experience with medical device regulatory processes, particularly FDA 510(k).
• Ability to manage multiple projects simultaneously and meet tight deadlines.

Skills

• Embedded Systems Design
• Electrical Safety Compliance
• EMC Testing
• Design Transfer and V&V
• Supplier Relationship Management

Benefits

Competitive compensation, comprehensive benefits package including medical and dental coverage, vision coverage, 401(k) with 4% matching contributions, basic life and AD&D insurance, unlimited vacation policy, 6 weeks paid maternity leave, and 10 paid holidays. Caldera Medical also supports community involvement and prioritizes diversity and inclusion.

Pay

Details TBD based on experience and qualifications.

Schedule

Full-time, on-site in Park City, Utah.

Company Culture

Caldera Medical fosters a culture where career and passion come together. Employees have a seat at the table and influence with management. The company cares about giving back to the community and aims to treat one million underserved women by 2027. Caldera Medical is an equal opportunity employer.