Principal Systems Engineer – Medical Devices Location: Croydon (Hybrid – 3 days office, 2 days WFH) Salary: £80,000 - 90,000 (depending on experience) The Opportunity We are recruiting on behalf of a leading medical device company for a Principal Systems Engineer. This is a senior role with technical ownership of new product development and product sustenance, ensuring projects meet strict regulatory, safety, and performance standards while delivering on time and within budget. Working as part of a dynamic R&D group, the Principal Systems Engineer will help shape technology roadmaps, lead on system architecture, and ensure compliance with international medical standards. This is a rare opportunity to combine deep technical expertise with strategic influence, driving the development of life-saving medical technologies. Key Responsibilities Define, manage, and document system requirements, including leading user workshops. Develop system architectures and evaluate alternative technologies. Ensure compliance with medical device standards such as ISO 14971, IEC 60601, and ISO 13485. Lead governance activities, including Critical Design Reviews (CDRs). Support Verification, Validation, and system qualification processes. Conduct detailed risk management activities (FMEAs, hazard analyses). Drive continuous improvement of engineering processes, tools, and lean design techniques. Monitor evolving regulatory requirements to ensure compliance. Share expertise across multidisciplinary teams and mentor junior engineers. About You Essential Requirements: Degree in Engineering or a related scientific discipline. Proven track record in developing complex, real-time systems in a regulated, safety-critical environment. Strong knowledge of systems engineering disciplines (requirements, architecture, V&V, release). Expertise in software, mechanics, electronics, or physics, with broad technical awareness across disciplines. Experience applying ISO 14971 risk management and IEC 60601 safety standards. Proficiency in systems engineering tools and methodologies (MBSE, SysML, UML). Strong analytical, problem-solving, and communication skills. Desirable: Experience in R&D within a medical device environment (ISO 13485 compliance). Knowledge of real-time control systems, PLCs, and networked system security. Strong commercial and business awareness. Excellent team player with a passion for advancing medical technologies. If you are interested in the role of Principle Systems Engineer and feel that you have the relevant experience, please contact your Recruitment Partner, Lisa Logan at Unicorn Resourcing on (phone number removed) or email (url removed) If this job isn't exactly right for you but you're looking for something new, please contact us for a confidential career discussion. Unicorn Resourcing Limited is acting as an Employment Agency in regard to this Permanent opportunity