Firmware Technical Lead - Medical Devices and Quality Systems in Newton

Location: Cambridge

Salary: We know salary transparency matters. While we can't list a figure on this advert, the client is genuinely flexible and open to shaping the package around the right person. The salary on offer is genuinely competitive.

Employment Type: Permanent

Working Arrangements: Onsite working

If you've ever wanted your firmware leadership to directly influence patient safety, this is that role. A Cambridge engineering organisation is building a new life‐sustaining wearable medical device from the ground up. Their hardware platform already ships globally in high‐volume consumer products; now it's being engineered into a regulated medical device for the first time. They're hiring a Firmware Technical Lead to define the architecture, development lifecycle, and quality systems that will underpin the entire product line.

Why this role matters

Most senior roles in medical firmware are about maintaining legacy systems. This isn't. You'll be joining a small, newly formed medical devices team at the moment everything is being defined: architecture, coding standards, IEC 62304 processes, verification strategy, toolchain, documentation, and cross‐functional quality alignment.

You get the rare combination of:

• A true greenfield mandate — set the firmware architecture, development standards, toolchain, and real‐time strategy
• Deep engineering support — established hardware, electronics, controls, and algorithms teams behind you
• Ownership of quality systems — shaping how IEC 62304, ISO 13485, ISO 14971, and cybersecurity requirements are implemented across firmware

The device itself is demanding: closed‐loop sensing and actuation, dose‐critical safety logic, fault tolerance, multi‐year power budgets, IEC 60601, IEC 62304 Class C software, and secure connected delivery. If you thrive in high‐integrity environments, you'll feel at home.

What you'll lead:

• Define and own the firmware architecture for a life‐sustaining wearable device
• Lead technical decisions on structure, standards, toolchain, and development processes
• Establish and maintain an IEC 62304‐aligned lifecycle (V‐model, traceability, verification, static analysis, unit testing)
• Partner with Quality and Regulatory to ensure alignment with ISO 13485, ISO 14971, IEC 60601, and cybersecurity standards
• Drive risk management activities and contribute to regulatory submissions (MDR, FDA)
• Mentor engineers as the team scales — starting with a hands‐on build phase, evolving into technical leadership
• Champion robust documentation, design reviews, and continuous improvement across the firmware function

What you'll bring:

• Several years of embedded firmware experience on a medical device that shipped under IEC 62304
• Strong embedded C (and some C++) with deep experience in low‐power, real‐time, bare‐metal or RTOS development
• Solid understanding of ISO 13485, ISO 14971, and safety‐critical engineering principles
• Experience defining or maturing firmware processes, standards, and quality systems
• Confidence to set direction where process doesn't yet exist — and the judgement to know what matters now vs. later
• A genuine motivation to build medical technology that directly impacts patient safety

Nice to have:

• Experience with medical device development
• FDA or MDR submission involvement
• Static analysis tools (MISRA, Coverity, Polyspace), unit testing frameworks, CI for embedded
• Cybersecurity for medical devices (FDA premarket guidance, IEC 81001‐5‐1)
• Secure boot, OTA updates, cryptographic key management

The trade‐off

The compensation is competitive for Cambridge, but the real draw is the influence: shaping a greenfield medical device inside a stable, well‐resourced engineering organisation. If you want to build something you'll be proud to point to in five years, this is that opportunity. Confidential conversations welcome.

Contact Cathy Swain for more information.