Senior Systems Engineer – IVD / Medical Devices

CY Partners; England; On-site; GBP 50,000 - 70,000; Full time

Job summary

A leading medical diagnostics organization in London is seeking a Senior Systems Engineer with expertise in In Vitro Diagnostics and a strong systems engineering background. This 12-month contract role involves developing reliable systems, mentoring teams, and ensuring compliance with industry standards. Ideal candidates will be BSc/MSc graduates with experience in regulated industries. This position offers a competitive salary and requires collaboration with international teams, including the US.

Qualifications

• Strong background within systems engineering, particularly in regulated industries.
• Knowledge of regulatory standards like ISO 13485 and IEC 62304.
• Experience in root cause analysis for electro-mechanical systems.

Responsibilities

• Develop reliable, cost-effective, and high-quality systems for IVD products.
• Act as a subject matter expert within systems engineering.
• Ensure documentation complies with ISO 13485 quality standards.

Skills

Systems engineering knowledge

Experience in In Vitro Diagnostics

Regulatory standards knowledge

Problem-solving approach

Education

BSc / MSc in Engineering or Computer Science

Tools

Model based systems engineering tools

Job description

Senior Systems Engineer – IVD / Medical Devices

12 month contract

Based in London

£ Highly competitive salary

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 are 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

• 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‑off’s 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.

Requirements

• 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 a 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.

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”

The recruiter has stated that all applicants for this job should be able to prove that they are legally entitled to work in the UK. CY Partners Recruitment Ltd, trading as CY Partners is an Employment Business / Agency.