Design Assurance Engineer
The Design Assurance Engineer will work closely with the Quality and R&D team, responsible for Medical Device (CE Mark, IDE & PMA) Design Assurance, Design Control and Risk Management Activities.
Key Responsibilities:
* Prepare and execute design verification and validation plans, protocols, and reports to ensure design documentation meets company and regulatory requirements.
* Oversee and manage testing completed both in-house and by external test houses, ensuring compliance with test protocols and all regulatory standards.
* Report, analyze, and make recommendations from test results or other process-related findings.
* Analyze 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 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 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 is an advantage.
* Knowledge of risk management activities – EN ISO14971.
* Product and process validation experience.
* Working knowledge of FDA QSR and EN ISO13485.
* Experience in the use of statistical techniques.