Medical Device Design Expert
4 days ago
About the Role:
This is an excellent opportunity for a Senior Design Quality Engineer to join our client, a Medical Device organization based in Dublin. As a key member of the design team, you will be responsible for ensuring compliance with regulatory requirements and standards.
Key Responsibilities:
- Support new product design and development, design transfer, design validation, design review, risk management, etc.
- Design control compliance, ensuring consistent, workable and compliant planning, development (inputs, outputs and review), testing (verification, validation and review), and change management.
- Regulatory compliance: ensuring product development (including software) and maintenance in accordance with FDA QSR's (21 CFR Part 820), ISO 13485, EU MDR, CMDR, MDD, J-PAL, IEC 62304 and relevant guidance documents.
- Design risk management, assuring appropriate and consistent risk management tool use i.e. FMEA, FTA, etc. for all programs and projects, compliant with regulatory standards (ISO/EN 14971) and industry practices.
Requirements:
- Bachelor degree in science, microbiology, engineering or equivalent technical field with 8+ years of applicable industry experience is required or a MS with 4+ years of applicable industry experience is required.
- Experience in medical device design control including software development and product realization.
- Competence in statistical tools including design of experiments and sampling methods.
- Experience in design quality assurance, risk management.
- Problem solving skills e.g root cause analysis and CAPA implementation.
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