Collins McNicholas currently have an exciting opportunity for an Engineering Manager with one of their clients in the Mid-West Region. This role is a permanent position.
The primary function of this position is to manage a team of Engineers focused on supporting the design and manufacturing process of devices post release to market, for the purpose of maintaining device quality, compliance, securing regulatory approval, as well as reducing costs and increasing yields.
The following are the key requirements for the role:
- Lead a team of engineers focused on the support of CAPAs (resulting in device design, process or procedural changes).
- Provide engineering input and support for the investigation and resolution of Non Conformances associated with devices post release to market.
- Provide engineering input and support to those responsible for Vendor instigated changes.
- Support Regulatory Affairs as required with engineering input for submissions and renewals post initial release of devices to market.
- Maintenance of those elements of the Risk management file for existing devices, for which engineering is responsible, including for example dFMEA, pFMEA, Risk Benefit Analysis.
- Support the post market surveillance of devices in terms of complaint investigation and risk analysis.
- Maintenance and remediation of Design History Files for existing devices to ensure compliance with relevant procedures, standards, or guidance documents.
- Liaise with R&D and Process Development teams to ensure the effective transfer of new devices from Development to Sustaining cycles.
- Responsible for the implementation and management of labelling
- Team Management:
- Mentoring, coaching and development of direct reports to attain best performance.
- Perform routine appraisals to deliver best results and to obtain the maximum team performance.
- Manage the activities of the Sustaining Engineering team and hold regular team meetings.
- Ensure KPI’s and business metrics are achieved.
- Ensure the Sustaining Engineering team are in compliance with Quality System requirements and Company HR policies.
- Liaise with other manufacturing facilities.
- Work closely to build effective relationships with Production, Quality and Regulatory teams.
- Responsible for operating general internal quality systems and documentation.
- Act as a Designee for the Senior Engineering Manager or Team Lead Engineer for change control review as per Quality System Procedures.
- Ensure that Code of Conduct is considered in all business matters
- Formal production/engineering qualification and relevant experience in both manufacturing engineering and/or device development.
- Strong proven people management skills – a minimum of 5 years previous experience in a supervisory position leading and motivating a group of talented engineering staff.
- Strong interpersonal skills and the ability to communicate across all levels of the organisation.
- Strong knowledge of medical device quality standards ISO13485/FDA practices and GMP or similar regulated industry standards.
- Proven problem-solving skills.
- Good computer skills including knowledge of Microsoft® Office.
- Excellent organisational and team building skills.
- High self-motivation.
- Willingness and availability to travel on company business.
For a confidential discussion on the above role please contact Michael O’Leary on 061-512270