Job Description
Overview
This role involves working as part of a research and development team to design, develop, and launch medical devices for global markets. Reporting to the team lead or manager, you will be responsible for leading technical development projects, managing project teams, and ensuring timely completion of project milestones.
You will work closely with cross-functional teams to achieve project and company goals, including building effective relationships with key stakeholders. Additionally, you will be responsible for mentoring and coaching team members, fostering innovation and creativity within the team, and ensuring compliance with quality and regulatory standards.
The ideal candidate will have a strong background in engineering or a related field, with a minimum of 5 years' experience in product development projects within the medical device industry. They should also possess proven project management skills, knowledge of medical device quality standards, and the ability to effectively translate needs of clinicians and business units into project inputs.
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Requirements
* Bachelor's degree in engineering or a related field
* Minimum 5 years' relevant experience in product development projects within the medical device industry
* Proven project/technical experience
* Project management methodology and skills
* Knowledge of medical device quality standards ISO13485/FDA practices, EUMDR, GMP and similar regulated industry standards
* Strong statistical understanding and experience (e.g., DOE and/or Gage R&R)
* Good working knowledge of Solidworks and/or Pro Engineer CAD
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Benefits
Cook Medical offers a comprehensive benefits package, including:
* Hybrid Work Model
* 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
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Working Environment
Cook Medical has been in Limerick since 1996 and currently employs over 1000 people. The Ireland location is our European headquarters and houses our EMEA Support Centre. Our R&D team in Limerick is split into two divisions: Vascular and Medsurg. We offer a collaborative and innovative environment that allows our engineers to create novel ideas, learn and meet the requirements to bring a medical device through verification and validation, generation of a Design History File, and be a part of bringing a new product onto the market.