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Director, Engineering

1 week ago

Limerick, Ireland Cook Medical Incorporated Full time

Overview The primary function of this role is to provide leadership and direction to the Post Market and Manufacturing Engineering teams, while taking overall responsibility for effective and efficient running of the department.
The Director, Engineering is also responsible for working with Local and Global Functional Leaders, and Divisions to manage all aspects of Post Market and Manufacturing Engineering at Cook Ireland.
Taking global functional direction, the Director, Engineering is a member of the CIRL senior leadership team.

Reporting to: Vice President and General Manager
Responsibilities Direct, mentor and manage the Post Market Engineering (CAPA, Design Sustaining & Clinical Communications), Manufacturing Engineering (New Product Introduction (NPI), Production Line Support, Calibration, Toolroom, & Process Improvement), Engineering Systems/Support and Engineering Test Lab (including Biocompatibility and Sterilisation) groups, ensuring resources and expertise are assigned to meet company goals and objectives.
Manage engineering costs and ensure a full understanding of departmental expenditure and budget.
Work closely with the Research and Development onsite and globally to build and maintain strong links with the engineering community within Cook.
Work closely with Research and Development to ensure efficient transfer of New Product Development products into manufacture via the NPI process.
Work closely with and support the Regulatory Affairs and Quality departments as required with Engineering technical expertise for design/manufacturing related submissions and renewals post initial release of devices to market.
Review and approval of the benefit-risk information in Clinical Evaluation Protocols (CEP) and Clinical Evaluation Reports (CER).
Engage with Operations and other functions to drive / deliver Continuous Improvement goals for Cook Ireland.
Seek out continuous improvement best practice with an emphasis on what can be learned and implemented at Cook Ireland to drive a best-in-class operation and eliminate waste from processes.
Foster relations with Post Market and Manufacturing Engineering leadership globally to understand and leverage best practice and synergies.
Communicate regular project updates both internally and externally – flag major issues and help to resolve in a timely manner.
Work closely with the Divisions and functional leadership to set priorities for Post Market and Manufacturing Engineering activities.
Assign projects and agree realistic targets and deadlines for completion of projects.
Monitor progress of projects and assist with problems and issues.
Ensure that the Post Market product development activities and risk analysis comply with ISO 13485 and FDA CFR 820 requirements.
Ensure the Management of the sterilisation programme at Cook Ireland including validation and re-validation of contract sterilisation.
Work closely with Quality, Regulatory and Operations departments to ensure all project elements are addressed sufficiently.
Facilitate and lead interdepartmental meetings as appropriate to resolve issues.
Ensure compliance to global policies, procedures and direction.
Support current manufacturing (products and processes) to optimise quality and efficiency.
Undertake people management responsibilities to the direct reports of this role, including but not limited generating training and developmental plans, carrying out performance appraisals and dealing with performance related issues in a timely manner.
Provide coaching and support to direct reports in their day to day roles and act as a point of escalation where necessary for issues that may arise.
Ensure open communication channels are maintained across all teams within Post Market and Manufacturing Engineering function, and that all information is cascaded appropriately and in a timely fashion.
Contribute and work as part of the local management team to help create a synergistic and cohesive environment.
Follow local policies and procedures including but not limited to quality, health and safety, human resources, travel and expense reporting.
Ensure that Cook's Code of Conduct is considered in all business matters.
Delegates for this position are the Manager, Manufacturing Engineering, the Manager, Post Market Engineering and the Manager, Engineering Test Lab.
Qualifications Bachelor's degree in engineering or related field is required and a minimum of 12 years' relevant experience.
An advanced Engineering degree (e.g.
Masters, PhD) is preferred.
Minimum of 7 years management experience leading engineering professionals.
A strong background in engineering, including product development and manufacturing processes.
Strong strategic and analytical abilities, diplomacy, negotiation and excellent oral and written communications skills; highly organised.
A successful track record of successful project completion.
Experienced in Medical Device regulatory environment globally, including Medical Device Directive and EU Medical Device Regulation 2017/745.
Excellent organisational and planning skills with a strong attention to detail.
Proven ability to form strong inter-personal relationships with colleagues throughout Europe and the US as well as plant-based personnel.
Demonstrated ability to work under pressure and meet deadlines.
Must be a strategic team builder with good business acumen, combined with hands-on approach.
Proficient use of Microsoft Office applications is required Proven leadership ability.
Willingness and availability to travel on company business.
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