Senior Quality Engineer

Description:

Senior Quality Engineer to join a rapidly growing, well-backed medical device company developing innovative organ preservation and perfusion technologies. With continued investment in product development and engineering, this is an opportunity to play a key role in advancing life-saving medical technology that directly supports organ transplantation.

You'll work closely with R&D and Software Engineering teams, providing independent Quality oversight throughout the product development lifecycle. This is a technically involved Design Assurance position, focused on medical device software, design controls, Quality Risk Management, verification and validation, and ensuring products meet regulatory requirements from initial development through commercialisation.

The opportunity offers significant ownership and technical influence within a growing MedTech organisation. You'll work across Software Engineering, R&D, Regulatory and Manufacturing, reviewing software requirements, architecture, risk controls and testing activities while helping drive design decisions and product release readiness. This is an opportunity to remain closely involved with engineering while taking responsibility for the broader Quality and regulatory requirements behind innovative medical devices.

Key experience:

• 7+ years of relevant engineering, Design Assurance, Quality or V&V experience, including 4+ years within the medical device industry.
• 4+ years of hands-on medical device Software Quality, software validation or Software Design Assurance experience.
• Strong experience with medical device design controls, design and development activities, DHF documentation and product lifecycle management.
• In-depth knowledge of ISO 13485, ISO 14971, IEC 62304 and FDA 21 CFR Part 820/QMSR, with EU MDR experience advantageous.
• Hands-on experience with Quality Risk Management, including hazard analysis, risk controls, FMEA and risk management documentation.
• Experience reviewing software requirements, architecture, V&V plans, test protocols, traceability matrices and software release documentation.
• Technical software background, including experience writing, debugging or formally reviewing code in C, C++, Python or similar languages.
• Familiarity with embedded medical device software, firmware, software safety classifications and hardware/software interfaces.
• Ability to independently assess technical documentation, challenge engineering decisions and provide Quality oversight throughout development and release.
• Strong cross-functional experience working with Software Engineering, R&D, Regulatory Affairs and Manufacturing teams.
• Experience with Git, Jira, Azure DevOps or similar software development tools advantageous.
• Experience with organ preservation, perfusion systems, connected medical devices or safety-critical software beneficial, but not essential.