Senior Systems Engineer (Medical Devices)

Senior Systems Engineer – IVD / Medical Devices
Permanent Position
Highly competitive salary + Excellent Benefits
Are you an experienced systems engineer, with a background in, and passion for In Vitro Diagnostics, Medical Devices or associated technologies?
Would you like to join a ground-breaking medical diagnostics organisation to support the advancement of their product development and commercialisation pipeline within the UK and US?
With an international presence, my client has already enjoyed commercial success from their technology and has a strong product development pipeline, so are looking to bring onboard a Senior Systems Engineer to accelerate their products through to the next phase of development and commercialisation.
As the Senior Systems Engineer, you will work cross-functionally within the wider business to develop reliable and high-quality systems, including defining system requirements, system architecture and system modelling, whilst also ensuring traceability of requirements and associated risks.
Utilise systems engineering knowledge to develop reliable, cost-effective and high quality systems for use in In Vitro Diagnostics (IVD) products.
Act as the subject matter expert within systems engineering, supporting and mentoring the multidisciplinary IVD development team.
Keep up to date with novel principles and practices for systems and reliability engineering, so as to develop innovative strategies to overcome product development hurdles.
Ensure documentation is completed in line with ISO 13485 quality standards.
Strong background within systems engineering, with experience working within In Vitro Diagnostics (IVD), medical devices, microfluidics or other complex and regulated industries.
Engineering, Computer Science etc.) or equivalent working experience.
Knowledge of regulatory standards e.g. ISO 13485, IEC 62304 and IVDR and an understanding of their importance when developing medical device software.
Experience conducting root cause analysis, particularly for electro-mechanical systems failures.
Familiar with applying software security risk management standards e.g., SW:96:2023 and implementing risk mitigations e.g. Understanding of broad engineering principles and instrument functionality related to medical devices, e.g. electrical systems, thermal dynamics, optics and data analysis.
Familiarity with Model based systems engineering tool(s) is highly beneficial.
A proven track record of having a problem solving approach, able to understand and overcome technical challenges in the field.
For further information, please apply online or contact Katie-May Kress at CY Partners for further information.
Key Words: “Senior Systems Engineer, Systems Engineer, Systems Engineering, Engineer, Engineering, Software Engineer, Software Design, Product Design, Verification and Validation, ISO 13485, IVDR, IEC 62304, SW:96:2023, ISO 27001, IEC 80001, IEC 60601, IVD, In Vitro Diagnostics, Medical Device, Microfluidics, London”