Develop and maintain Engineering Operations Systems. Standardise local procedures for new product introduction and engineering activities to reflect the global procedures and policies ensuring an efficient and compliant process, whilst simultaneously ensuring compliance with the latest revisions of medical device directives, FDA CFR 820, ISO 13485, ISO 14971 and other relevant industry standards. This role incorporates the review of the relevant standards and the integration of their interpretation into our QMS.
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Develop and maintain Engineering quality systems and procedures for product and process design controls.
Liaise with Global Operations Teams and review global procedures ensuring alignment of procedures globally and locally to streamline design control and new product introduction processes for most efficient project completions.
Ensure Engineering quality systems comply with latest revisions of medical device directives, FDA CFR 820, ISO 13485, ISO 14971 and other relevant industry standards. This incorporates the review of the relevant standards and the integration of their interpretation into our QMS.
Benchmark Engineering operating systems against best practices and implement changes to further improve efficiency.
Manage Quality Systems compliance within Post-market and Manufacturing Engineering group.
Develop and Maintain Project log and system for Engineering.
Ensure consistent use of product and process controls across engineering group.
Participate in notified body audits.
Manage the IP disclosure, prioritisation and filing process for Cook Ireland Engineering.
Manage implementation of Project tracker system.
Coordinate with R&D, Post-market and Manufacturing Engineering Managers to ensure needs are met.
Lead the Engineers/Technicians allocated.
Ensure high engineering standards are established, implemented and maintained across all engineering groups.
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.
Seek out continuous improvement best practise with an emphasis on what can be learned and implemented at Cook Ireland to drive a best in class operation and efficient processes.
Drive team to ensure business metrics are achieved.
Act as a designee of the Senior Engineering Manager.
Develop and maintain strong working engineering relationships with the global engineering operations team and other Cook sites.
Regular communication to local and external management.
Support cross functional teams to achieve company goals.
Ensure that Cook’s Code of Conduct is considered in all business matters carried out on Cook’s behalf.
Third level degree in Mechanical, Biomedical, Design, Chemical engineering/science or similar discipline.
5 Years design experience preferable in a senior medical device role.
Proven Leadership abilities.
Comprehensive knowledge of medical device quality & regulatory systems and medical device directives (ISO13485 and FDA CFR 820), and EU Medical Device Regulation 2017/745.
Expert in Design control systems.
Good Project Management methodology and skills.
Proven track record in delivering quality results in a timely effective manner.
Good mechanical design, manufacturing process design, materials and engineering standards.
Strong communication and inter-personal skills.
Good presentation skills (working knowledge of MS PowerPoint).
Strong technical writer.
Team Player with ability to develop strong working relationships.
Good problem solving skills.
Highly motivated individual, self-starter with a passion for excellence.
Willingness and availability to travel on company business.