Job Description
The Design Assurance Engineer will work closely with the Quality and R&D team to ensure medical device design assurance, control, and risk management activities meet international standards.
Daily Responsibilities:
* Develop and execute design verification and validation plans, protocols, and reports in accordance with company and regulatory requirements.
* Oversee testing completed in-house and by external test houses, ensuring compliance with test protocols and regulatory standards.
* Analyse and report test results, making recommendations as necessary.
* Evaluate test data to establish performance standards for new products or processes.
* Create quality and technical documentation to support design activities and quality system requirements.
* Design and implement test fixturing to support data generation and design verification testing.
* Lead design teams on risk analysis and essential requirements assessments.
* Support product realisation teams during new product launches.
* Own ERs and CAPAs, driving root cause investigations and corrective actions for design assurance issues.
* Support continuous improvement of quality system processes and overall business operations.
Requirements:
* Bachelor's degree in Biomedical Engineering or relevant field.
* Minimum 3 years of experience in a quality role in a medical device environment (design assurance experience preferred).
* Knowledge of risk management activities (EN ISO14971).
* Product and process validation experience.
* Working knowledge of FDA QSR and EN ISO13485.
* Experience with statistical techniques.