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R&D Manager

  • Sector: Engineering
  • Contact: Rhys Joyce
  • Contact Email: rhys.joyce@collinsmcnicholas.ie
  • Job Ref: 17796

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.


Key Responsibilities

  • 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.

Qualifications

  • 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.

091-706718

rhys.joyce@collinsmcnicholas.ie