Overview
Senior Design Assurance Engineer - Endovascular Devices
Location: Galway, IrelandIndustry: Medical Devices (Endovascular)Employment Type: Permanent, Full-Time
The role
As a Senior Design Assurance Engineer, you will act as a quality leader within the R&D and product development teams. You\'ll drive compliance, risk management and design control activities across the full product lifecycle, ensuring that endovascular systems meet the highest standards of safety, reliability, and performance.
You will be a critical voice in design reviews, regulatory submissions, validation strategies, and continuous improvement initiatives.
Responsibilities
Lead Design Assurance support for new product development (NPD) and design changes to endovascular devices.
Ensure full compliance with ISO 13485, FDA 21 CFR 820, and relevant endovascular standards.
Drive risk management activities in alignment with ISO 14971, including hazard analysis, FMEAs, and fault tree analysis.
Partner closely with R&D to define design inputs, verification/validation (V&V) strategies, and technical documentation.
Review and approve design protocols, reports, DHFs, and key quality documentation.
Support regulatory submissions by providing high‑quality evidence packages and technical input.
Lead root cause investigations and apply strong statistical/quality engineering problem‑solving methods.
Mentor junior engineers and contribute to strengthening design quality culture within the organisation.
Requirements
Experience in Design Assurance, R&D Quality, or Product Development within the medical device sector.
Strong experience with class II/III devices, ideally endovascular, cardiovascular, or catheter‑based systems.
Deep understanding of design controls, risk management and V&V best practices.
Excellent communication skills, with the ability to influence cross‑functional teams.
Analytical mindset with experience using root cause analysis and statistical tools.
#J-18808-Ljbffr