Principal Medical Software Engineer
Ensera Design4 months ago
Bristol, United KingdomStaff+
Responsibilities
- Lead the design, development, verification, and delivery of software for regulated medical devices, including IEC 62304 Class C safety-critical software.
- Provide technical direction across the full software lifecycle while ensuring regulatory compliance, robust architecture, and high-quality execution.
- Shape architectures for medium to large-scale medical software systems and oversee technology selection, architecture trade-offs, and risk-reduction strategies.
- Review and approve detailed designs, code, verification plans, and safety-related artefacts.
- Guide integration of software with digital design, electronics, firmware, mechanical, and human-factors teams.
- Communicate with internal stakeholders, clients, and regulatory bodies.
- Support cybersecurity considerations, automated test frameworks, simulators, hardware-in-the-loop setups, and integrations with hospital systems as applicable.
Requirements
- Demonstrable experience developing medical software from planning through regulatory submission.
- Proven experience delivering IEC 62304 Class C safety-critical software to market.
- Experience developing embedded medical-device software using environments such as Linux, QNX, or SafeRTOS.
- Experience developing software requirements specifications and shaping medium to large-scale software architectures.
- Ability to oversee technical decisions, architecture trade-offs, risk-reduction strategies, and cybersecurity considerations.
- Experience reviewing and approving detailed design, code, verification plans, and safety-related artefacts.
- Experience guiding integration across software, digital design, electronics, firmware, mechanical, and human-factors disciplines.
- Desirable experience with FDA medical-device cybersecurity guidance, UL 2900, IEC 81001, automated test frameworks, simulators, hardware-in-the-loop setups, EHRs, DICOM, HL7, and client-facing consultancy.
Benefits
- Initial 18-month fixed-term contract.
- Flexible hybrid working aligned with agreed working patterns and core hours.
- Performance-related company-wide bonus.
- Private healthcare for the employee and family.
- Enhanced maternity and paternity leave.
- Salary exchange pension scheme.
- 25 days of annual leave, with options to purchase additional leave and receive extra days for length of service.
- Employee Assistance Programme and digital wellbeing platform.
- Cycle to Work and Electric Vehicle Lease schemes.
- Death-in-service benefit of four times gross salary.
- Training and development opportunities, dedicated learning days, and knowledge-sharing sessions.
- Free monthly lunch, weekly breakfast, team activities, and summer and Christmas parties.
About Ensera Design
Ensera Design is a healthcare-focused design and product development consultancy serving pharma, medical device, and consumer health companies, offering research, human factors, industrial and digital design, and engineering through to prototyping, testing, and design for manufacture. Headquartered in Bristol with studios in Morristown (NJ) and Frederick (CO), it is part of SteriPack Group. The firm supports regulated product development, aligning design with manufacturing and regulatory requirements to bring market-ready devices and digital experiences to life.