Design Assurance Manager

Galway
Permanent
Full-time

12 hours ago

Design Assurance ManagerWe are seeking an experienced Design Assurance Manager to lead design assurance activities across all stages of the product lifecycle within a dynamic and fast-paced medical device environment.This position offers the opportunity to play a key leadership role in ensuring product and process development activities meet applicable regulatory and quality system requirements, while supporting efficient innovation in an entrepreneurial setting.The successful candidate will provide expertise in design controls, risk management, and verification & validation, working cross-functionally with R&D, Quality, Manufacturing, and Regulatory Affairs teams, as well as external partners, to ensure the delivery of safe, effective, and compliant medical devices.A hands-on approach, strong work ethic, and the ability to thrive in a flexible environment are essential.Key Responsibilities

Lead and manage Design Assurance activities throughout the product lifecycle in accordance with Design Control requirements
Ensure compliance with applicable regulatory standards including ISO 13485 and FDA 21 CFR Part 820 (including QMSR transition)
Support design, process, and supplier changes impacting commercial products, ensuring adherence to design control and change management requirements
Assess the impact of manufacturing, material, supplier, and equipment changes on product safety, performance, and regulatory compliance
Ensure appropriate risk assessments are conducted for manufacturing and process changes
Lead or support design change evaluations, including defining verification, validation, and biocompatibility requirements
Drive the implementation and maintenance of risk management processes in line with ISO 14971
Ensure risk management files are established, maintained, and reviewed throughout the product lifecycle
Lead periodic risk reviews for marketed products, ensuring alignment with post-market surveillance data
Monitor post-market data (complaints, CAPA, field actions, vigilance reports) to identify and manage emerging risks
Maintain and update benefit-risk assessments as required
Support integration of risk management outputs into usability engineering, clinical evaluation, and regulatory submissions
Collaborate with Regulatory Affairs to support regulatory strategy and submission readiness
Lead or support internal and external audits (including regulatory inspections and notified body audits)

Skills & Experience

Bachelor’s degree in Engineering, Science, or a related discipline
Minimum of 8 years’ experience in the medical device industry or equivalent advanced postgraduate qualification (Master’s or PhD)
Strong knowledge of medical device quality and regulatory systems, including ISO 13485 and FDA 21 CFR Part 820
Proven experience in Design Controls and Risk Management (ISO 14971)
Demonstrated experience supporting lifecycle management of commercial medical devices, including design and manufacturing changes
Experience in design verification and validation, biocompatibility, and design transfer activities
Solid understanding of mechanical engineering principles
Knowledge of medical device materials and manufacturing processes
Strong project management, communication, and technical writing skills
Ability to operate effectively in a cross-functional, fast-paced environment

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