Job Description
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.
091 706713
christopher.otoole@collinsmcnicholas.ie
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