Senior Design Assurance Engineer

Join a dynamic product development team driving the creation of a cutting-edge, software-driven medical device console. As the Design Assurance Engineer, you’ll play a pivotal role in embedding safety, quality, and compliance into every stage of the product lifecycle. This position demands strong expertise in IEC 62304 (software lifecycle), IEC 60601 (electrical safety), ISO 13485, ISO 14971, and ISO 62366, with a focus on ensuring regulatory readiness and robust design controls.

You’ll collaborate closely with cross-functional teams—especially R&D—to guide verification and validation (V&V) activities, risk management, and documentation that support global regulatory submissions and successful commercialisation. Your contributions will directly impact patient safety and product performance.

Key Responsibilities:

• Ensure compliance with FDA 21 CFR and international standards including ISO 13485, ISO 14971, IEC 62304, IEC 60601, and ISO 62366.
• Partner with engineering teams to implement design controls, risk management strategies, and V&V protocols aligned with regulatory expectations.
• Develop and validate test methods for hardware and software systems, ensuring traceability from requirements through testing.
• Lead and support design reviews, maintain the Design History File (DHF), and ensure documentation integrity.
• Stay current with evolving regulatory requirements and contribute to continuous improvement of design assurance processes.
• Provide technical expertise during audits and regulatory submissions, and mentor team members on best practices in embedded systems, usability engineering, and cybersecurity.
• This is a unique opportunity to influence the development of a high-impact medical device, working in a fast-paced, mission-driven environment focused on innovation and improving patient outcomes.