Job Description:
As a member of our Medical Device organization based in Dublin, you will have the opportunity to work with a leading multinational company at the forefront of their industry.
This role is ideal for individuals who are passionate about contributing to the design and development of innovative medical devices that improve patient outcomes.
Key Responsibilities:
1. Support new product design and development, working closely with Device Engineering through the entire product life cycle.
2. Ensure design control compliance by implementing consistent and compliant planning, development, testing, and change management processes.
3. Maintain regulatory compliance by ensuring product development and maintenance align with FDA QSR's (21 CFR Part 820), ISO 13485, EU MDR, CMDR, MDD, J-PAL, IEC 62304, and relevant guidance documents.
4. Assure appropriate and consistent risk management tool use, such as FMEA and FTA, for all programs and projects, in accordance with regulatory standards (ISO/EN 14971) and industry practices.
5. Contribute to pre- and post-market risk assessments, working closely with other functions such as Global Design Engineering, Manufacturing, Regulatory, Product Monitoring, Clinical, and Operations.
6. Perform internal and supplier audits, and contribute to the development of audit plans and procedures.
7. Lead personnel within the Quality organization in support of business needs, including supplier qualification, vendor management, and performance evaluation.
Education & Experience:
* Bachelor's degree in science, microbiology, engineering, or equivalent technical field, with 8+ years of applicable industry experience, or a Master's degree with 4+ years of applicable industry experience.
* Experience in medical device design control, 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, and root cause analysis.
* Understanding of one or more subsystem technologies: electrical, mechanical, pneumatic, and/or software systems.
* Knowledge of medical device regulations, including FDA, GMP, design controls, ISO 13485, EU MDR, IEC 62304, and ISO 14971.
* Lead auditor certification.
* Experience in supplier management.