Job Title
We are seeking an experienced professional to join our Medical Device organization based in Dublin.
This is an excellent opportunity for individuals who want to work with a leading multinational company that excels in its industry.
Duties and Responsibilities
* Product Design and Development: Support the design, development, and validation of new products, working closely with Device Engineering throughout the product life cycle.
* Design Control Compliance: Ensure consistent planning, development, testing, and change management processes are in place to meet regulatory requirements.
* Regulatory Compliance: Oversee product development and maintenance to ensure compliance with FDA QSRs, ISO 13485, EU MDR, CMDR, MDD, J-PAL, IEC 62304, and relevant guidance documents.
* Design Risk Management: Implement risk management tools such as FMEA and FTA to identify and mitigate potential risks.
* Risk Assessments: Supervise and contribute to pre- and post-market risk assessments.
* Collaboration: Interact with Global Design Engineering, Manufacturing, Regulatory, Product Monitoring, Clinical, and Operations teams as needed.
* Audits: Perform internal and supplier audits.
* Leadership: Lead personnel within the Quality organization as required.
* Supplier Management: Qualify, manage, and evaluate suppliers.
Education and Experience Requirements
* Education: Bachelor's degree in science, microbiology, engineering, or equivalent technical field.
* Experience: 8+ years of applicable industry experience or MS with 4+ years of applicable industry experience.
* Skills: Statistical tools, design of experiments, sampling methods, design quality assurance, risk management, problem-solving, human factors, user-interface design, medical device regulations, lead auditor certification, and supplier management.