Lead Medical Software Engineer — Class C, Embedded

HS Design, Inc.; Bristol; Hybrid; GBP 70,000 - 89,000; Full time

Benefits offered by this job

Performance-related bonus

Hybrid working policies

Private healthcare for you and family

Salary exchange pension scheme

25 days annual leave (+ extra)

Training and development opportunities

Company-wide meals and social events

Job summary

Ensera Design is a world-class design and development consultancy for medical and consumer health sectors. We seek a Medical Software Engineer for an 18-month fixed-term project, leading software for regulated medical devices and guiding lifecycle activities with a focus on regulatory compliance and robust architecture.

You will work across teams including digital design, electronics, firmware, and HF, with opportunities to shape architecture, cyber security, and integration with hospital

Qualifications

• Experience developing software requirements specifications (SRS).
• Experience shaping the architecture of medium to large scale medical software systems.
• Oversee technical decision making including technology selection, architecture trade-offs, risk reduction, and cyber security considerations.
• Review and approve detailed design, code, verification plans, and safety artefacts.
• Guide integration of software with digital design, electronics, firmware, mechanical and HF teams.
• Cybersecurity for medical devices (FDA guidance, UL 2900, IEC 81001).
• Develop automated test frameworks, simulators, or hardware-in-the-loop setups.
• Integrate with hospital systems (EHRs, DICOM, HL7).
• Experience working in client-facing and consultancy roles.

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 high quality execution.

Skills

Medical software development

Embedded software

Regulatory compliance

SRS development

System architecture

Cyber security

Software verification & testing

Healthcare integration (EHR/HL7/DICOM)

Client-facing consultancy

Job description

Ensera Design is a world-class design and development consultancy for medical and consumer health sectors. We seek a Medical Software Engineer for an 18-month fixed-term project, leading software for regulated medical devices and guiding lifecycle activities with a focus on regulatory compliance and robust architecture.

You will work across teams including digital design, electronics, firmware, and HF, with opportunities to shape architecture, cyber security, and integration with hospital