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$70k–$89k/yr
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…
Skills: Medical Software Development, IEC 62304 Class C, Embedded Systems, Software Requirements Specifications (SRS), Software Architecture
Bristol, England, United Kingdom · Hybrid
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Bristol, England, United Kingdom · Hybrid
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Lead the design, development, and delivery of safety-critical software for regulated medical devices, specifically IEC 62304 Class C. Provide technical direction across the full software lifecycle while coordinating with internal stakeholders, clients, and regulatory bodies.
Requires extensive experience in medical software development, specifically delivering Class C safety-critical software for embedded environments. Candidates must be proficient in creating SRS, shaping system architecture, and managing cybersecurity and risk reduction strategies.
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.
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 [email protected].
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.
Better healthcare. Brought to life.
Ensera Design is the design and product development consultancy where future healthcare solutions become a market reality. We have studios in Bristol (UK), Morristown (NJ) and Frederick (CO), each with strategic importance to our global design practice. Created by uniting award-winning studios HS Design and Kinneir Dufort, we bring together deep user, technology and medical understanding into close alignment with the manufacturing know-how and regulatory expertise of the wider Ensera group, to deliver breakthrough product innovation destined for commercial success. Our international team of experts stands side-by-side with our ambitious pharma, medical device and consumer health clients, collaborating to deliver better health outcomes for all, no matter how complex the need. This is: Better healthcare. Brought to life. Learn more at www.enseradesign.com *Ensera Design is a trading name of Kinneir Dufort Ltd and HS Design Inc.
Offices: 5 Host Street, Bristol, BS1 5BU, GB · 906 Mount Kemble Ave, Morristown, New Jersey 07960, US · 5900 Keyes St, Suite 102, Frederick, Colorado 80504, US
