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Design Assurance Engineer II

  • Sector: Engineering
  • Contact Email: christopher.otoole@collinsmcnicholas.ie
  • Job Ref: 23359

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.

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For a confidential discussion on the role and organisation please contact Chris O Toole

091 706713

christopher.otoole@collinsmcnicholas.ie