Director, Quality Design Engineering

At Smith+Nephew, we design and manufacture technology that takes the limits off living. If you are passionate about elevating the quality, safety and performance of medical devices that transform patient outcomes, this is your opportunity to lead a talented team at the heart of our innovation. Join us as we continue to shape the future of Advanced Wound Management with purpose and impact.

In this role, you will guide a team of Design Quality Engineers and Sustaining Engineers who act as the guardians of design integrity across our Advanced Wound Management portfolio. Your days will be varied and purposeful, collaborating with cross-functional partners to ensure that every device we develop or maintain meets the highest global standards. You will independently review design work throughout the development lifecycle, steward our design control processes and oversee Design History Files to ensure completeness and compliance. Working closely with research and development and sustaining engineering teams, you will help translate design inputs into effective verification and validation activities, and you will support operations and quality assurance teams to ensure seamless and compliant transfer of products to manufacturing.

Risk management will be central to your work, from maintaining Risk Management Files to advising on health hazard evaluations and ensuring that user instructions reflect product risk accurately and clearly. You will also help shape and refine our ways of working, continuously improving processes and deploying resources effectively to support a high performing, collaborative team.

Success in this role means leading a team that acts as a trusted authority on design quality across our Advanced Wound Management products. You will see well governed design control and change processes that withstand internal and external scrutiny and ensure safety and clinical confidence in every device. Your guidance will help teams make informed, risk aware decisions, and your leadership will enable timely, high quality outputs that support both new product development and the long term performance of marketed products. Your team will develop under your direction, growing in capability and confidence, and the processes you champion will remain fit for purpose, clearly understood and continuously improved. Ultimately, success will look like safe, effective and compliant products that have a meaningful impact on the lives of people who rely on them.

What you need to be successful:

• A degree in a relevant life science or engineering discipline plus substantial experience in a design quality or research and development environment
• Expert knowledge of medical device risk management and design control, including ISO 14971 and ISO 13485
• Strong understanding of global quality system regulations including FDA QSR, EU MDR, GMP standards and applicable ISO frameworks
• Experience with electronic mechanical devices, software driven products or wound care technologies

We are committed to welcoming, celebrating and growing on diversity. Learn more about our Employee Inclusion Groups on our website.

Generous annual bonus and pension schemes, Save As You Earn share options. Flexible vacation and time off, paid holidays and paid volunteering hours so we can give back to our communities. Private health and dental plans, healthcare cash plans, income protection, life assurance and much more. Hybrid working model for most professional roles. Hands on, team customised mentoring and development. Discounts on gyms and fitness clubs, salary sacrifice bicycle and car schemes and many other employee discounts.

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