Senior Systems Engineer - 6 Month Contract About the Role
We are seeking a Senior Systems Engineer on a contract basis with a strong background in medical device development. This role involves leading the design and integration of complex electro-mechanical systems, ensuring robust architecture, regulatory compliance, and effective cross-functional collaboration.
You'll contribute to the development of safe and effective medical technologies by integrating hardware, software, and fluidics in regulated clinical environments.
Key Responsibilities
Lead systems engineering activities for electro-mechanical medical device platforms.
Translate user needs and clinical requirements into system-level specifications.
Define and manage requirements traceability, risk analysis, and design inputs/outputs.
Collaborate with cross-functional teams (mechanical, electrical, software, quality, regulatory) to ensure integrated product development.
Support design verification and validation (V&V), including test planning and execution.
Ensure compliance with FDA 21 CFR Part 820, ISO 13485, and IEC 60601 standards.
Participate in design reviews, FMEA, and hazard analysis.
Provide technical leadership and mentorship to junior engineers.
Ideal Candidate Profile
Proven experience in medical device systems engineering, ideally with electro-mechanical or drug delivery systems.
Strong understanding of embedded software, fluidics, and hardware integration.
Familiarity with design controls, risk management, and regulatory compliance.
Excellent communication and documentation skills.
Ability to work independently and collaboratively in a fast-paced, regulated environment.
Preferred Qualifications
Bachelor's or Master's degree in Systems Engineering, Biomedical Engineering, Electrical/Mechanical Engineering, or related field.
5+ years of experience in medical device product development.
Experience with tools such as DOORS, Jama, or equivalent for requirements management.
Knowledge of IEC 62304, ISO 14971, and human factors engineering is a plus.Please click to find out more about our Key Information Documents. Please note that the documents provided contain generic information. If we are successful in finding you an assignment, you will receive a Key Information Document which will be specific to the vendor set-up you have chosen and your placement.
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Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Business in relation to this vacancy | Registered office | 8 Bishopsgate, London, EC2N 4BQ, United Kingdom | Partnership Number | OC(phone number removed) England and Wales