Principal Medical Software Engineer

About the role

Ensera Design is a world-class user-centred innovation and product development consultancy, specializing in the medical and consumer health sectors with offices in Bristol, Colorado and New Jersey. As part of Ensera, we collaborate globally with contract manufacturing facilities in Europe, the USA, and Asia.

We are currently seeking an experienced Medical Software Engineer to join our growing team to be a part of our largest current project on a fixed-term basis (initially 18-months), so it is an exciting time to join us.

The role will be responsible for:

• Leading the design, development, verification and delivery of software for regulated medical devices, including IEC 62304 Class C safety-critical software.

• Providing technical direction across the full software lifecycle, ensuring regulatory compliance, robust architecture, and high quality execution whilst communicating with internal stakeholders, clients and regulatory bodies.

About you

You’ll have demonstrable experience of medical software development, spanning everything from planning to submission. You’ll have proven experience of delivering Class C safety critical software to market and be comfortable developing for embedded environments i.e. Medical Device Software built on Linux, QNX, SafeRTOS etc.

Collaboration plays a vital part in what we do so you’ll be a natural team player, eager to work and learn with others across expertise areas.

Your skills and experience

Whilst you do not need to meet all of these points, please ensure you meet the majority of them before making an application:

• Experience developing software requirements specifications (SRS).

• Experience shaping the architecture of medium to large scale medical software systems.

• Be comfortable enough to oversee technical decision making including technology selection, architecture trade-offs, risk reduction strategies, and cyber security considerations.

• Be able to review and approve detailed design, code, verification plans, and safety-related artefacts.

• Demonstrable experience of guiding integration of software with digital design, electronics, firmware, mechanical and HF teams.

Desirable skills

• Cybersecurity for medical devices (FDA pre/post-market guidance, UL 2900, IEC 81001 etc.).

• Development of automated test frameworks, simulators, or hardware-in-the-loop setups.

• Experience integrating with hospital systems (EHRs, DICOM, HL7 protocols etc.).

• Experience working in client-facing and consultancy roles.

The salary for this role is in line with the middle to top-end of our Principal salary banding, £70,000 to £89,000. We ask you to confirm your salary expectations as part of your application and we further ask you to really consider where you feel your experience sits within that band.