Senior Systems Engineer, Medical Devices, Electro-mechanical Systems, Risk, Compliance, ISO 13485, C

Senior Systems Engineer, Medical Devices, Electro-mechanical Systems, Risk, Compliance, ISO 13485, COR7121 A rare and exciting opportunity has arisen for an experienced Senior Systems Engineer to join a pioneering scientific R&D company that specializes in the development of medical devices. The Role The Senior Systems Engineer will join a multidisciplinary team to lead the development of a next-generation NGS platform for in-vitro diagnostic applications. The role involves defining and managing system requirements, designing and executing experiments, and ensuring traceability and compliance with regulatory standards. You will bridge electronics, software, and other development teams, applying systems engineering principles to create reliable, cost-effective solutions. As a technical leader, you will mentor team members, lead design reviews, and develop innovative strategies to overcome product development challenges while maintaining quality documentation in line with ISO 13485 standards. The Company The Senior Systems Engineer will join an innovative organization that is dominating its field, creating pioneering devices that are having an enormous impact within the medical field. The company has gone from strength to strength and is looking for passionate Systems Engineers to support their expansion. Benefits Flexible working, including remote working Excellent opportunities for career advancement 25 days Holiday Pension scheme What’s required of the Senior Systems Engineer? Proven experience in Systems Engineering, ideally within the medical device industry Experience with regulatory standards such as ISO 13485, IEC 62304, and IVDR, along with risk management standards like ISO 27001 or IEC 80001 Hands-on experience with system design and root-cause analysis for electro-mechanical systems. Expertise in bridging software and electronics teams, with knowledge of engineering principles across electrical systems, thermal dynamics, and data analysis. What Next? If you’re a Software Security Engineer / Software Security Specialist looking to work on a meaningful product that will make a huge impact on the medical field, then please apply today to learn more! #J-18808-Ljbffr