Design Assurance ManagerThis 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 OpportunityReporting 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 strategyDrive best-in‑class design control and risk management practicesPartner closely with R&D, Manufacturing, Quality, and Regulatory teamsPlay a key role in regulatory readiness and audit successYou won’t just maintain systems — you’ll build, improve, and scale them.Key ResponsibilitiesLead Design Assurance activities across all stages of the product lifecycle in line with Design Control requirementsEnsure compliance with ISO 13485, FDA 21 CFR Part 820 (and QMSR transition) and other global regulatory standardsProvide oversight and guidance on design, process, and supplier changes impacting commercial productsAssess the impact of manufacturing, material, supplier, and equipment changes on product safety and complianceLead and maintain risk management processes in accordance with ISO 14971 across the full product lifecycleOwn and continuously improve risk management files, ensuring alignment with post‑market dataDrive periodic risk reviews and ensure benefit‑risk profiles remain currentMonitor post‑market data (complaints, CAPA, vigilance) to identify emerging risks and implement actionsLead or support design change evaluations, including verification, validation, and biocompatibility requirementsSupport integration of risk outputs into usability engineering, clinical evaluation, and regulatory submissionsPartner with Regulatory Affairs on submission strategy and readinessLead and support internal and external audits (FDA, Notified Bodies, regulatory authorities)What We’re Looking ForEssential ExperienceBachelor’s degree in Engineering, Science, or related discipline8+ years’ experience in the medical device industryStrong knowledge of ISO 13485 and FDA 21 CFR Part 820Deep expertise in Design Controls and Risk Management (ISO 14971)Proven experience supporting commercial product lifecycle activities, including design and manufacturing changesExperience in design verification & validation, design transfer, and biocompatibilityStrong project management, communication, and technical writing skillsDesirable ExperienceAdvanced degree (Master’s or PhD)Strong understanding of mechanical design and engineering fundamentalsKnowledge of medical device materials and manufacturing processesExperience operating in a scaling or entrepreneurial MedTech environmentWhy Join?High‑impact role with direct reporting line to senior leadership (COO)Opportunity to shape and scale Design Assurance and Risk Management frameworksWork at the forefront of innovative medical device developmentJoin a collaborative, cross‑functional team in a growing organisationEnvironment that values ownership, flexibility, and hands‑on contributionReal opportunity to influence both product outcomes and company growth trajectoryApply NowIf 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 james.cassidy@lifescience.ie or call in confidence 086 0204322 for a confidential discussion.
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