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Contact Info
Thomas Gallagher
Life Science

+353870612325
[email protected]
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Details

Senior Manufacturing Engineer


Reference:A011744 Location: Galway
Galway City
Qualification:DegreeExperience:5-7 Years
Job Type:PermanentSalary: Not Disclosed

Role: Senior Manufacturing Engineer

Location: Oranmore, Galway

Benefits: Excellent salary, pension, healthcare, yearly bonus and share options.



Company:

My client is expanding our Engineering team, currently recruiting for a Senior Manufacturing Engineer to focus and apply knowledge of technical principles and systems/procedures to optimise manufacturing processes. This is an exciting opportunity to get involved in the highly innovative and rapidly growing world of minimally invasive ENT therapeutic devices




Requirements:

  • Full responsibility for the process development life cycle from ideation through to commercial validation.
  • Participate in supplier selection for device manufacture, tooling and components.
  • Identify and ensure implementation of opportunities to optimize/improve manufacturing processes using engineering methods (e.g., SIX Sigma and LEAN methods)
  • Employing technical skills to design and ensure equipment, tools, fixtures, etc are up to standards.
  • Develop state-of-the-art understanding of relevant products and processes.
  • Develop and maintain operational processes and procedures incorporating industry best practices and in compliance with appropriate regulatory requirements.
  • Plan and track elements of product development, new product introductions and technology transfers, ensuring adherence to project timelines.
  • Develop complex experiments and tests (including writing and executing protocols) to qualify and validate manufacturing processes; analyse results, make recommendations, and develop reports.
  • Analyse and resolve complex Manufacturing and Compliance issues (e.g., CAPA, non-conformances, audit observations).



Experience needed:
  • Degree level 8 in Engineering or related discipline with 5 years + relevant experience – additional relevant qualifications may be advantageous.
  • Experienced with medical device process and manufacturing development and project/program management, risk analysis and problem-solving skills.
  • Knowledge of design verification and process validations, particularly as it pertains to equipment and manufacturing processes.
  • Dynamic team player and can work effectively and proactively on cross-functional teams.
  • Excellent understanding of ISO 13485 and FDA design and development processes.
  • Experience working with medical device lab/industrial equipment required.



To apply and to hear more forward your CV to the link attached or contact me at [email protected] or call 087 0612325.