Senior Medical Systems Engineer: Architecture & Compliance

Inspiration Healthcare; Croydon; On-site; GBP 75,000 - 110,000; Full time

Job summary

Inspiration Healthcare in Croydon is seeking a Senior Systems Engineer to lead new product development and sustenance, ensuring projects meet scope, time, cost, and quality targets within a regulated medical device context.

You will own the technical architecture, drive roadmaps, perform risk analyses (ISO 14971) and ensure compliance with IEC 60601-1, ISO/IEC/IEEE 15288, and cross-functional collaboration across engineering, quality, regulatory, and clinical teams.

Qualifications

• Bachelor's degree in a relevant engineering or scientific discipline.
• Proven analytical and problem-solving skills, particularly in high-reliability, life-supporting systems such as ventilators.
• Demonstrated experience translating risk management process standards (ISO 14971) into practical and compliant development methodologies for medical devices.
• Proven ability to interpret and apply product‑specific standards for basic safety and essential performance (IEC 60601‑1) into robust system design solutions for ventilator platforms.
• Background in core systems engineering disciplines: Requirements Management, Architecture Definition, System Design, Verification, Validation, Assurance, and Release.
• Comfortable working in cross-functional teams and across diverse projects, with the flexibility to adapt to rapidly evolving development priorities.

Responsibilities

• Specify and manage system requirements, including facilitation of user workshops.
• Develop and maintain system architecture and design in alignment with user and stakeholder needs.
• Generate engineering documentation suitable for handoff to downstream design and development teams.
• Lead and support engineering governance activities, including Critical Design Reviews (CDRs).
• Collaborate with V&V teams to support verification and validation, including defect triage and issue resolution.
• Attend and contribute to project meetings, providing technical input, risk assessment, and continuous improvement opportunities.
• Share knowledge and technical expertise across project teams and functional areas.
• Monitor and interpret changes in regulatory standards to ensure design compliance with safety and performance criteria.

Skills

Analytical problem solving

Risk management

Requirements engineering

Systems thinking

Cross-functional collaboration

Communication skills

Education

Bachelor's degree in engineering or sciences

Tools

FMEA

ISO 14971

IEC 60601-1

ISO/IEC/IEEE 15288

Job description

Inspiration Healthcare in Croydon is seeking a Senior Systems Engineer to lead new product development and sustenance, ensuring projects meet scope, time, cost, and quality targets within a regulated medical device context.

You will own the technical architecture, drive roadmaps, perform risk analyses (ISO 14971) and ensure compliance with IEC 60601-1, ISO/IEC/IEEE 15288, and cross-functional collaboration across engineering, quality, regulatory, and clinical teams.