Senior Systems Engineer IVD / Medical Devices
Permanent Position
Based in London
£ 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?
My client is a well-funded and trail-blazing MedTech company with a disruptive microfluidics based diagnostics platform, providing fast and insightful near-patient analysis for a range of unmet clinical needs. 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.
Key Responsibilities of the
Senior Systems Engineer
will include: Utilise systems engineering knowledge to develop reliable, cost-effective and high-quality systems for use in In Vitro Diagnostics (IVD) products. Drive system improvement through communicating requirements with internal and external developers and stakeholders. Own the system design input documentation and traceability matrix, ensuring records are accurate and updated in a timely manner. Act as the subject matter expert within systems engineering, supporting and mentoring the multidisciplinary IVD development team. Design, undertake and analyse experiments to assess requirements and plan next steps. Participate in product development phases and design reviews, identifying and negotiating trade-offs as needed. 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.
To be considered for the
Senior Systems Engineer
vacancy, you will need the following skills and experience: Strong background within systems engineering, with experience working within In Vitro Diagnostics (IVD), medical devices, microfluidics or other complex and regulated industries. BSc / MSc in a relevant discipline (e.g. 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. ISO 27001, IEC 80001, and IEC 60601. 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. Proven ability to work effectively with global, cross-functional teams, and manage relationships with key internal and external stakeholders. A proven track record of having a problem-solving approach, able to understand and overcome technical challenges in the field. Please note this role will involve collaboration with UK and international teams (including the US), so flexibility to work across time zones is required. For further information, please apply online or contact Katie-May Kress at CY Partners for further information.
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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?
My client is a well-funded and trail-blazing MedTech company with a disruptive microfluidics based diagnostics platform, providing fast and insightful near-patient analysis for a range of unmet clinical needs. 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.
Key Responsibilities of the
Senior Systems Engineer
will include: Utilise systems engineering knowledge to develop reliable, cost-effective and high-quality systems for use in In Vitro Diagnostics (IVD) products. Drive system improvement through communicating requirements with internal and external developers and stakeholders. Own the system design input documentation and traceability matrix, ensuring records are accurate and updated in a timely manner. Act as the subject matter expert within systems engineering, supporting and mentoring the multidisciplinary IVD development team. Design, undertake and analyse experiments to assess requirements and plan next steps. Participate in product development phases and design reviews, identifying and negotiating trade-offs as needed. 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.
To be considered for the
Senior Systems Engineer
vacancy, you will need the following skills and experience: Strong background within systems engineering, with experience working within In Vitro Diagnostics (IVD), medical devices, microfluidics or other complex and regulated industries. BSc / MSc in a relevant discipline (e.g. 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. ISO 27001, IEC 80001, and IEC 60601. 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. Proven ability to work effectively with global, cross-functional teams, and manage relationships with key internal and external stakeholders. A proven track record of having a problem-solving approach, able to understand and overcome technical challenges in the field. Please note this role will involve collaboration with UK and international teams (including the US), so flexibility to work across time zones is required. For further information, please apply online or contact Katie-May Kress at CY Partners for further information.
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