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Job Description
Senior Design Assurance Engineer sought to lead product lifecycle, risk management, and design control systems for a leading Medical Device company in Galway.
A highly experienced individual is required to oversee sustaining activities, contribute to New Product Development, and lead EU MDR projects.
The ideal candidate will have expertise in ISO 13485 and ISO 14971 Quality and Risk Management systems, as well as a strong understanding of statistics and validation.
Job Responsibilities
- Support the development of Design Control, Risk Management, and associated systems.
- Lead sustaining activities, focusing on design changes to meet business needs and regulatory requirements.
- Manage risk management activities for assigned projects, ensuring compliance with ISO 14971 and company procedures.
- Develop and maintain design verification and validation plans, protocols, and reports for design changes.
- Contribute to the design, development, and validation of test methods for development programs.
- Lead Human Factors / Usability Engineering activities and maintain Usability Engineering Files for assigned projects.
- Manage the system for Design History File creation and maintenance for new and commercialised devices.
Requirements
- At least 5 years of experience in a Quality or Design Assurance role in the Medical Device industry, preferably with Class III Medical Devices.
- Bachelor's degree or higher in Science, Engineering, or a related discipline.
- Excellent understanding of ISO 13485 and ISO 14971 Quality and Risk Management systems.
- Strong understanding of statistics and validation principles.