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Job Description
Medical Device Design Control Specialist required to support product development and ensure regulatory compliance.
We're recruiting for a Medical Device organization based in Dublin, where you'll work closely with Device Engineering through the entire product life cycle.
Key Responsibilities:
- Support new product design and development, design transfer, design validation, design review, risk management, etc.
- Ensure design control compliance, including planning, development, testing, and change management.
- Regulatory compliance: ensure product development and maintenance in accordance with FDA QSR's, ISO 13485, EU MDR, and relevant guidance documents.
- Design risk management, using tools such as FMEA and FTA, for all programs and projects.
- Supervise and contribute to pre- and post-market risk assessments.
- Interact with other functions, such as Global Design Engineering, Manufacturing, Regulatory, and Operations.
- Perform internal and supplier audits.
- Lead personnel within the Quality organization, as necessary.
- Supplier qualification, vendor management, and performance evaluation.
Requirements:
- Bachelor's degree in science, microbiology, engineering, or equivalent technical field, with 8+ years of applicable industry experience.
- 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, and problem-solving skills.
- Understanding of one or more subsystem technologies, including electrical, mechanical, pneumatic, and software systems.
- Understanding of human factors and user-interface design.
- Knowledge of medical device regulations, including FDA, GMP, design controls, ISO 13485, EU MDR, and IEC 62304.
- Lead auditor certification.
- Experience in supplier management.