Would you like to join a leading medical device company in Limerick, to further develop your career, and ensure the quality of medical devices for patients around the world?
The primary function of this opportunity, is to lead engineering participation in post market surveillance (PMS) and participate in projects focused on design and / or process modifications of devices, post release to market, for the purpose of maintaining device quality and compliance.
Reporting to: Senior Sustaining Engineer
Engineering representative on the PMS team. The qualified candidate for this position should excel in an environment that embraces teamwork, change, risk-based decision making and flexibility. This individual should be willing to make a significant contribution to a cross functional team, must be self-motivated to take action, and have excellent written and verbal communication skills. Candidate will support efforts to ensure Regulatory compliance.
Evaluation of medical devices regarding their risk potential
Represent Engineering at cross-functional team meetings
Provide an Engineering interpretation of the analysis of clinical and non-clinical data pertinent to Cook Ireland medical devices (e.g., complaints trends, literature reviews, abstracts, posters, presentations, manuscripts, Clinical Evaluation Reports, and clinical study reports).
Review trending data and use engineering knowledge and risk based approaches to identify when corrective actions are required.
Support the post market surveillance of devices in terms of complaint investigation and risk analysis.
Provide engineering support for post market clinical studies if required.
Identify and implement updates to risk management and PMS process to ensure regulatory compliance
Update governing risk management documents (dFMEA/pFMEA) to facilitate post market surveillance feedback.
Formal science/production/engineering qualification and relevant experience in at least one of the following areas :
Medical Device Design & Development/ Risk management
Strong project management skills (proven track record of same desirable)
Strong interpersonal skills and the ability to communicate across functions.
Material or pharmaceutical ingredient knowledge an advantage.
Strong engineering ability to understand medical device designs
Knowledge of clinical trials an advantage.
Strong written and verbal communication skills are required, as is the ability to effectively communicate with cross-functional teams and program managers.
Previous medical device experience desirable, in particular with medical device regulations.
Working knowledge of Design Controls, GMPs, ISO13485 and ISO14971 quality requirements is preferred.
If you would like further Information you can contact the recruiter directly:
Kevin Silke | Tel: +353 (0) 1 507 9255