A great new opportunity to join a global leader in the Medical Device Sector. My client is looking for an R&D Manager to join their growing Structural Heart team here in Galway.
- 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.
- Ensures that NCEP’s and eCAPA’s are investigated to determine root cause and that appropriate corrective actions are applied.
- 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.
- 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 a confidential discussion and more information on the role please contact Rhys Joyce.