Job ID: JOB-11992
Our client a leading medical device company is recruiting for a highly motivated and experienced R&D Manager to join the Galway R&D team. This role is commutable from Clare and Mayo.
Seeking a highly motivated and experienced person for the role of R&D Manager. The successful candidate will lead and manage lab testing activities while ensuring compliance to procedures and standards and oversee the work of the test method engineers who support development and validation of new test methodologies. The successful candidate would be responsible for providing significant guidance to the R&D team technical strategies and would represent R&D team in all areas of test method development and validation. The candidate would set the bar for excellence within the function and look for development opportunities for all within the group to achieve that functional excellence at all levels.
- Ensures that the testing executed in laboratories are conducted in accordance with cGMP and recognised standards
- Shall provide support and guidance in the areas of cGMP, compliance, regulatory, technical investigations, validation, test method optimization, technical transfers
- Ensures that projects are completed on schedule following established procedures and schedules and promotes a work environment of continuous improvement
- Ensure employees are trained to do their work and their training is documented.
- Oversees the test method engineering teams work to develop and validate test methods
- Supervision of the development and/or transfer of test methods into laboratory and validation of those tests.
- Maintains knowledge of test method development, validation and transfer procedures including equipment qualification
- Ensures work is carried out with consideration of the latest technology, standards, and regulations
- Familiar with the internal and external auditing processes and represents the lab at a management level for audits.
- Selection and recruitment of laboratory staff and test method engineers as required in conjunction with Human Resources.
- Ensures performance reviews of staff are conducted and are effective with a plan the development of laboratory and engineering staff.
- Manages the budgets for the laboratories and oversee procurements of lab equipment and supplies
- Understands and proactively follows through on the environmental and safety management procedures to maintain a good and safe working environment
- Works across multiple functions to ensure the labs capabilities continue to meet the businesses needs and develops a vision for the future direction of the lab
- Contributes to New Product Development strategic initiatives
- In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
Qualifications & Requirements:
A bachelor’s degree in Mechanical Engineering, Biomedical Engineering or relevant Life Science discipline is required. An advanced degree is a distinct advantage.
- 9+ years experience with BS Degree
- 7+ years experience with MS Degree
- 4+ years experience with PhD
Position requires relevant experience to include medical device development, exposure to design of experiments, measurement system analysis, test method development and validation. A working knowledge of equipment lifecycle management and software validation would be advantageous.
For further information on this R&D Manager role in Galway please contact Deirdre Finnerty on 086 3073779/ email@example.com
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