We are currently seeking a talented individual to join our Medical Device organization based in Dublin. This is an exciting opportunity for someone who wants to work with a leading multinational that excels in its field.
Duties
* Support the development of new products, from design and transfer to validation and review, working closely with Device Engineering throughout the product life cycle.
* Ensure design control compliance by maintaining consistent planning, development, testing, and change management processes.
* Ensure regulatory compliance by developing and maintaining products according to FDA QSR's, ISO 13485, EU MDR, CMDR, MDD, J-PAL, IEC 62304, and relevant guidance documents.
* Manage design risks by using appropriate risk management tools, such as FMEA and FTA, and ensuring compliance with regulatory standards and industry practices.
* Contribute to pre- and post-market risk assessments and interact with other functions as necessary.
* Perform internal and supplier audits.
* This role may require leading personnel within the Quality organization to support business needs.
* Qualify suppliers, manage vendors, and evaluate their performance.
Education & Experience
* A Bachelor's degree in science, microbiology, engineering, or an equivalent technical field, plus 8+ years of applicable industry experience, or a Master's degree with 4+ 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 and risk management.
* Problem-solving skills, including root cause analysis and CAPA implementation.
* Understanding of one or more subsystem technologies: electrical, mechanical, pneumatic, and/or software systems.
* Knowledge of human factors and user-interface design.
* Familiarity with medical device regulations, including FDA, GMP, design controls, ISO 13485, EU MDR, IEC 62304, and ISO 14971.
* Lead auditor certification.
* Experience in supplier management.