We’re currently recruiting for an exciting opportunity with a Medical Device organization based in Dublin. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.


Duties

- Support new product design and development, design transfer, design validation, design review, risk management, etc. working closely with Device Engineering through the entire product life cycle.
- Design control compliance ensuring consistent, workable and compliant planning, development (inputs, outputs and review), testing (verification, validation and review), and change management;
- Regulatory compliance: ensuring product development (including software) and maintenance in accordance with FDA QSR's (21 CFR Part 820), ISO 13485, EU MDR, CMDR, MDD, J-PAL, IEC 62304 and relevant guidance documents (FDA, etc)
- Design risk management, assuring appropriate and consistent risk management tool use i.e. FMEA, FTA, etc. for all programs and projects, compliant with regulatory standards (ISO/EN 14971) and industry practices,
- Supervision of and contribution to pre- and post- market risk assessments;
- Interact with other functions such as Global Design Engineering (GDE), Manufacturing, Regulatory, Product Monitoring, Clinical and Operations as necessary
- Perform internal and supplier audits
- This role may be required to lead personnel (inside and outside) within the Quality organization in support of the business need
- Supplier qualification, vendor management and performance evaluation

Education & Experience

- Bachelor degree in science, microbiology, engineering or equivalent technical field with 8+ years of applicable industry experience is required or a MS with 4+ years of applicable industry experience is required.
- 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
- Problem solving skills e.g root cause analysis and CAPA implementation
- Understanding of one or more subsystem technologies: electrical, mechanical pneumatic and / or software systems
- Understanding of human factors and user-interface design
- Knowledge of medical device regulations including FDA, GMP, design controls, ISO 13485, EU MDR, IEC 62304, ISO 14971, etc.
- Lead auditor certification
- Experience in supplier management


If interested in this posting please feel free to contact Seán McCarthy on +353 (0)87 798 8480 or [email protected] for further information.