Principal Medical Software Engineer
Ensera Design2 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.