The primary function of this position is to support the Engineering Laboratory manager in the development of systems and personnel in the Test Laboratory.
- Execute projects to continually improve how the test lab operates.
- Maintain and introduce systems to support changes to the regulatory landscape and the latest standards requirements.
- Active & proactive communication with sister companies to implement organisation wide standard operating procedures
- Liaise with equipment and service providers to identify suitable equipment/software to satisfy product test requirements.
- Maintain knowledge and develop additional expertise in standards associated with medical device product testing.
- Work in a tightly regulated environment regarding quality procedures and regulatory requirements.
- Provide leadership and mentoring to team members to ensure their development and the effective completion of the activities associated with their role.
- Review and approve documentation associated with laboratory management systems and testing related documentation conducted in the Test Laboratory on behalf of Cook.
- In the Lab Mangers absence, schedule test activities as necessary.
- Work in a multi-faceted environment interacting with people involved in all aspects of the business.
- Ensure that Cook’s Code of Conduct is considered in all business matters carried out on Cook’s behalf.
- This role is a delegate for the Engineering Laboratory Manager.
- Third level degree in Mechanical Engineering, Biomedical Engineering, Electrical/Electronic Engineering, Microbiology or similar Engineering/ Science discipline.
- At least five years’ work experience preferably in the medical device industry in a Test Lab, Engineering or Quality systems role.
- Passion to continually learn and motivate those around you.
- Proven track record in delivering quality results in a timely effective manner.
- Strong Technical writer.
- Team-player with ability to develop strong working relationships.
- Excellent communications and inter-personal skills.
- Highly motivated individual, self-starter with a passion for excellence.
- Knowledge of Test method development and validation activities desirable
- Experience in executing Gauge R&R studies, Attribute agreement analysis and Minitab comparison tools such as T tests desirable but not essential.
- Knowledge and experience of ISO13485, ISO 14971, ISO17025, EU MDR and the FDA CFR Title 21 Parts 58 desirable but not essential.
- Willingness and availability to travel on company business
About Cook Medical
Since 1963, Cook Medical has been finding solutions to improve the world’s healthcare problems for the patients and doctors we serve. As one of the world’s largest private companies, we have always operated with our patients, customers, employees and communities at our core. We do this, not only because it is good business, but also because we believe that being a good corporate citizen is the right thing to do.
Cook Medical has been in Limerick since 1993. Since opening, we have become a European headquarters for many of Cook’s business functions.
With a global workforce of over 12,000, we employ over 9 50 people in Ireland who bring Endoscopy, Urology and Peripheral Intervention products from conception to commercialisation.
Our employee benefits include:
- Hybrid working – mix of remote & onsite
- Company sponsored Defined Contribution pension scheme
- Medical Health Insurance cover for you and your immediate family
- Life Assurance and Income Protection cover
- Educational Assistance
- Performance related Bonus
- Extensive health & wellness program including Indian head massages, healthy lifestyle seminars, mindfulness courses, physio sessions, flu vaccinations, nutrition talks
- Fully equipped gym on site
- 39-hour week with flexible start & finish times
- Paid time off to participate in volunteer activities
- Free parking
- Subsidised restaurant
- Sports & Social club
To be considered for this role you will be redirected to and must complete the application process on our careers page. To start the process click the Continue to Application or Login/Register to apply button below.