Principal Medical Software Engineer

enseradesign; Bristol; On-site; GBP 70,000 - 89,000; Part time

Benefits offered by this job

Private healthcare for you and your 가족

Flexible hybrid working

25 days annual leave

Salary exchange pension

Lunch benefits

Job summary

Ensera Design is a world-class consultancy focused on medical and consumer health, delivering software for regulated devices across embedded platforms. We are seeking a Medical Software Engineer for an 18-month fixed-term project, joining a collaborative team and contributing to safety-critical development under IEC 62304.

You will lead design, verification and delivery across the software lifecycle, shaping architecture, risk reduction, cybersecurity considerations and regulatory compliance in

Qualifications

• Experience developing software requirements specifications (SRS).
• Experience shaping the architecture of medium to large scale medical software systems.
• Oversee technical decisions including technology selection, architecture trade-offs, risk reduction, and cyber security considerations.
• Review and approve detailed design, code, verification plans, and safety-related artefacts.
• Guide integration of software with digital design, electronics, firmware, mechanical and HF teams.

Responsibilities

• Lead the design, development, verification and delivery of software for regulated medical devices (IEC 62304 Class C).
• Provide technical direction across the full software lifecycle, ensuring regulatory compliance and robust architecture.
• Communicate with internal stakeholders, clients and regulatory bodies to align on deliverables.
• Collaborate with cross-disciplinary teams across medical device software development.

Skills

SRS development

Architecture design

Cybersecurity

Regulatory compliance

Embedded software

Team collaboration

Tools

Linux

QNX

SafeRTOS

Job description

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.

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 (Mon–Thu, 9:30am–12:00pm & 2:00pm–4:00pm; Fri, 9:30am–12:00pm).
• 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, we’re just a short walk from Park Street, the Harbourside, and St. Nick’s 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 what’s 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 you’d like to discuss the role or would like to discuss any reasonable adjustments you may need to make your application, we’d 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 [e-mail].