Design Assurance Manager

Design Assurance Manager

This is a rare opportunity to step into a high-impact Design Assurance leadership role within a scaling medical device company where your work will directly influence the safety, performance, and success of innovative products reaching patients globally. If you thrive at the intersection of engineering, quality, and regulatory strategy, and want to play a pivotal role in a fast-moving, entrepreneurial environment - this is the role that puts you at the centre of it all.

We are working with a growing, innovation-driven medical device company advancing cutting-edge technologies from development through to commercialisation. Operating in a fast-paced, highly collaborative environment, the organisation combines deep technical expertise with a strong commitment to quality and regulatory excellence. With ambitious growth plans, this is an opportunity to join at a key stage and help shape both the products and the systems that support them.

The Opportunity

Reporting directly to the COO, you will lead Design Assurance activities across the full product lifecycle, ensuring that development and commercial products meet the highest standards of safety, compliance, and performance. This is a high-visibility, cross-functional leadership role where you will:

• Influence product development strategy
• Drive best-in class design control and risk management practices
• Partner closely with R&D, Manufacturing, Quality, and Regulatory teams
• Play a key role in regulatory readiness and audit success

You won't just maintain systems - you'll build, improve, and scale them.

Key Responsibilities

• Lead Design Assurance activities across all stages of the product lifecycle in line with Design Control requirements
• Ensure compliance with ISO 13485, FDA 21 CFR Part 820 (and QMSR transition) and other global regulatory standards
• Provide oversight and guidance on design, process, and supplier changes impacting commercial products
• Assess the impact of manufacturing, material, supplier, and equipment changes on product safety and compliance
• Lead and maintain risk management processes in accordance with ISO 14971 across the full product lifecycle
• Own and continuously improve risk management files, ensuring alignment with post market data
• Drive periodic risk reviews and ensure benefit risk profiles remain current
• Monitor post market data (complaints, CAPA, vigilance) to identify emerging risks and implement actions
• Lead or support design change evaluations, including verification, validation, and biocompatibility requirements
• Support integration of risk outputs into usability engineering, clinical evaluation, and regulatory submissions
• Partner with Regulatory Affairs on submission strategy and readiness
• Lead and support internal and external audits (FDA, Notified Bodies, regulatory authorities)

What We're Looking For Essential Experience

• Bachelor's degree in Engineering, Science, or related discipline
• 8+ years' experience in the medical device industry
• Strong knowledge of ISO 13485 and FDA 21 CFR Part 820
• Deep expertise in Design Controls and Risk Management (ISO 14971)
• Proven experience supporting commercial product lifecycle activities, including design and manufacturing changes
• Experience in design verification & validation, design transfer, and biocompatibility
• Strong project management, communication, and technical writing skills

Desirable Experience

• Advanced degree (Master's or PhD)
• Strong understanding of mechanical design and engineering fundamentals
• Knowledge of medical device materials and manufacturing processes
• Experience operating in a scaling or entrepreneurial MedTech environment

Why Join?

• High impact role with direct reporting line to senior leadership (COO)
• Opportunity to shape and scale Design Assurance and Risk Management frameworks
• Work at the forefront of innovative medical device development
• Join a collaborative, cross functional team in a growing organisation
• Environment that values ownership, flexibility, and hands on contribution
• Real opportunity to influence both product outcomes and company growth trajectory

Apply Now

If you're a Design Assurance professional looking to step into a role where you can lead, influence, and build within a high growth MedTech company, we'd love to hear from you.

Apply now or reach out to James Cassidy or call in confidence for a confidential discussion.