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

Youll have demonstrable experience of medical software development spanning everything from planning to submission. Youll 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 youll 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 70000 to 89000. 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.

Why work with us

Ensera Design offers interesting and varied work combined with a supportive team culture to provide a stimulating environment where you will have the opportunity to develop and learn from others. We offer flexible working policies where working patterns are agreed with our line managers taking into account the role needs of the individual and the team.

We recognise that we are only as good as our people and we know how important it is to support our team.

We offer:

• Performance-related company-wide bonus.

• Flexible hybrid working in line with our core hours (MonThu 9:30am12:00pm & 2:00pm4:00pm; Fri 9:30am12:00pm).

• Private healthcare for you and your family.

• Enhanced maternity and paternity leave.

• Salary exchange pension scheme.

• 25 days of annual leave plus the option to purchase up to one working week and additional days for length of service.

• Access to our Employee Assistance Programme and digital wellbeing platform.

• Cycle to Work & Electric Vehicle Lease schemes.

• Death in service (x4 gross salary).

• Training and development opportunities including dedicated learning days and regular knowledge-sharing sessions.

• A free lunch the first Monday of every month alongside our company-wide meeting.

• Free breakfast every Wednesday and plenty of opportunities to socialise including team-organized activities summer and Christmas parties and more.

About us

We are based in an iconic Grade II listed building in the heart of Bristol. Our vibrant workspace houses state-of-the-art labs a design studio usability suites and collaborative meeting spaces. Nestled in a lively neighbourhood with independent shops were just a short walk from Park Street the Harbourside and St. Nicks Markets.

We are proud of our values:

• Find a way: We work as one team combining our knowledge and experience to unite around a shared goal. We trust each other and do whats needed to get things done and exceed expectations.

• Pull together: We believe anything is possible. When faced with challenges we take the initiative using our creative spirit and determination to find bold solutions and deliver results that move us forward.

• Care: We act with integrity take pride in our work and support each other. We each play our part to make a positive impact for our customers our colleagues and our planet.

Our diverse multidisciplinary team spans research design human factors engineering prototyping manufacturing and beyond. Together we deliver cutting-edge solutions for clients ranging from global leaders to innovative start-ups with a particular focus on medical devices drug delivery orthopaedics and diagnostics.

Do we sound like a good match for you

If youd like to discuss the role or would like to discuss any reasonable adjustments you may need to make your application wed love to hear from you. If you think you might be the right person for us but want an informal chat first then get in touch via .

Please note we reserve the right to close the vacancy earlier if we have a high level of applications. We look forward to hearing from you!

At Ensera Design we believe that designing for people means including all people starting with the team behind the work. Our human-centred design ethos is rooted in empathy and our values pull together find a way and care guide us in building a team that reflects the diversity of the world we design for.

We know that different perspectives lead to better ideas stronger collaboration and more meaningful outcomes. If you meet the skills and experience for this role we welcome your application whatever your background identity or path into design. What matters to us is that you share our belief in purposeful people-first design.

Polite notice for agencies We appreciate the interest from recruitment partners; however we are managing this hiring process directly and ask that agencies do not contact us regarding this role. Unsolicited CVs will be considered as a gift to Ensera Design.