Design Assurance Engineer Ii

Overview: The Design Assurance Engineer will work closely with the Quality and R&D team and be responsible for Medical Device (CE Mark, IDE & PMA) Design Assurance, Design Control and Risk Management Activities.
The Design Assurance Engineer will work as part of a team to assist in the development of innovative medical devices in accordance with the requirements of International Standards: ISO 13485:2016, the FDA Code of Federal Regulations 21 CFR Part 820 and 2007/47/EC, Medical Device Regulation (EU) 2017/745 and our clients QMS.
Day to day: Prepare and execute (in conjunction with the design teams) design verification and validation plans, protocols and reports ensuring design documentation meets the company and regulatory requirements.Oversee and manage testing completed both in-house and by external test houses on behalf of our client, ensuring compliance with test protocols and all regulatory standards.Report, analyse, and make appropriate recommendations from test results or other process related findings.Analyse test data to establish performance standards for newly implemented or modified products/processes.Generate quality and technical documentation to support design activities and quality system requirements including maintenance of Design History Files.Identify, design and implement test fixturing to support data generation and Design Verification testing.Lead design teams on the preparation of risk analysis and essential requirements assessments.Support the Product Realisation Teams as new products are developed and launched onto the market.Lead and own ERs and CAPAs as designated, driving root cause investigations and corrective actions for design assurance issues.Support the continuous improvement of quality system processes and the overall business.Requirements: Level 8 Degree in Biomedical Engineering or relevant qualifications.Minimum 3 years in a Quality Role in a medical device environment (Design Assurance experience a significant advantage).Knowledge of risk management activities – EN ISO14971.Product and process validation experience.Working knowledge of FDA QSR and EN ISO13485.Experience in use of statistical techniques.For a confidential discussion on the role and organisation please contact Chris O Toole at 091 706713 or ******.

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