Job title: Principal Design Assurance Engineer Location: Parkmore Business Park, Galway.
Benefits: Excellent salary, bonus, pension, healthcare, opportunity to grow your career with hugely exciting Medical Device organisation.
Company: My client are an early stage Irish MedTech company located in Galway, a global centre for excellence in medical technologies.
The company collaborates with clinicians and research institutions across the world developing and commercialising a new technology platform for endovascular surgery that will focus initially on patients with Critical limb ischemia.
About the role: As a Senior Design Assurance Engineer is to be the QA technical and compliance expert as part of a cross functional team for the design and development of sterile medical devices and /or subsequent modifications thereafter in compliance to current Regulatory requirements i.e. ISO *****, CFR 820 and governing Regulatory Standards associated with the product classification.
Lead the following activities from a quality perspective: • Risk Assessments • Device testing and associated validations • Audits i.e. Critical Suppliers, Self-Inspections, • On-going continuous improvement of the QMS • Generation and /or approval of technical documents on behalf of the Quality Function.
Responsibilities: - Responsible for compliance of product development and risk management activities with Medical Policies and Procedures and applicable Governing Regulatory Requirements.
- Work effectively as part of product development team in identifying and translating user requirements into design requirements, identifying critical design features and components, and contributing towards or leading the generation of risk management documents and associated quality documents, reports etc .
- Complete design verification, design validation and test method validation activities associated with product development activities.
- Works with R