Would you like to join a well known medical device comapny in Limerick, to further develop your career, and ensure the quality of medical device products for patients worldwide?
Lead a team of engineers focused on any one of the following Sustaining Engineering areas - CAPA, Design or Manufacturing.
Provide leadership and mentoring to team members to ensure their development and the effective completion of the activities associated with their role.
Work with Sustaining Engineering Manager and other Snr. Engineers to ensure the appropriate allocation of resources and prioritisation of efforts for the overall Sustaining Engineering group.
Collaborate with other Sustaining Engineering Teams to ensure the effective completion of all activities associated with a Sustaining Engineering project / objective.
Ensure effective reporting to the Sustaining Engineering Manager.
Work closely to build effective relationships with other functions in particular Production, Quality and Regulatory teams.
Reporting to: Sustaining Engineering Manager
Lead a team of engineers focused on the support / completion of CAPAs (related to design, procedures and systems, or manufacturing processes).
Identify and guide team in the successful implementation of:
Design changes that will improve existing device quality, performance and efficacy.
Cost reduction and yield/efficiency improvement opportunities.
Support Regulatory Affairs as required with engineering input for design related submissions and renewals post initial release of devices to market.
Maintenance and remediation of Design History Files for existing devices to ensure compliance with relevant procedures, standards or guidance documents.
Identify and guide the team in the successful implementation of:
Liaise with R&D and Process Development teams to ensure the effective transfer of new devices from Development to Sustaining cycles.
Responsible for process engineering layout plans and implementation in relation to line extensions or redesign.
Support the post market surveillance of devices in terms of complaint investigation and risk analysis.
5 years expereince previous experience in medical device industry.
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