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 [email protected] or call in confidence 086 0204322 for a confidential discussion.
