Senior Systems Engineer

Senior Systems Engineer

Medical Devices | Systems Engineering | New Product Development | Design Controls

A high-growth medical device company is seeking a Senior Systems Engineer to lead the development of innovative, next-generation medical technologies. This is a unique opportunity to take ownership of complex product development programmes, guiding products from concept through regulatory approval and commercial launch.

Working at the intersection of mechanical, electrical and software engineering, you will play a pivotal role in defining system architecture, driving verification and validation activities, managing risk and ensuring compliance with global medical device regulations.

The Opportunity

As a Senior Systems Engineer, you will serve as a technical leader across multidisciplinary product development projects, collaborating closely with engineering, quality, regulatory and manufacturing teams. You will lead Design Controls, Risk Management and systems engineering activities while ensuring products meet technical, quality and regulatory requirements.

This position is ideal for an engineer who enjoys solving complex technical challenges, working across multiple disciplines and influencing product strategy in a fast-paced, innovative environment.

Key Responsibilities

• Lead the development of complex medical devices incorporating mechanical, electrical and software components.
• Define and maintain system architecture, interfaces and requirements traceability throughout the product lifecycle.
• Drive Design Controls and Risk Management activities in accordance with FDA and international standards.
• Lead Verification & Validation (V&V) strategy, planning and execution, including protocol development, testing and reporting.
• Manage external engineering, testing and manufacturing partners to ensure project milestones are achieved.
• Develop and maintain system requirements, design documentation, risk management files and traceability matrices.
• Support regulatory submissions including 510(k), PMA and technical documentation activities.
• Lead product performance investigations, data analysis and design improvement initiatives.
• Coordinate testing to applicable IEC, ISO, ASTM and AAMI standards.
• Collaborate with manufacturing teams to ensure successful product industrialisation and market readiness.

What We're Looking For

• Bachelor's degree in Mechanical, Electrical, Biomedical, Software Engineering or a related discipline.
• 7 years of medical device product development experience.
• Proven experience leading Design Control and Risk Management programmes.
• Strong systems engineering experience across mechanical, electrical and software-based products.
• Hands-on experience with Verification & Validation planning, execution and test method validation.
• Knowledge of:
• FDA QMSR / 21 CFR Part 820
• ISO 14971
• ISO 13485
• IEC 60601 Series
• IEC 62304
• ISO 10993
• Experience with requirements management and traceability tools such as Jama, DOORS or Polarion.
• Excellent problem-solving, communication and project leadership skills.

Preferred Experience

• Cardiac monitoring, ECG, electrophysiology or other connected medical device technologies.
• Electromechanical and software-driven medical devices.
• Catheter-based technologies.
• Experience within start-up or high-growth medical device environments.
• Familiarity with embedded software, firmware development or Python.