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Manufacturing Engineer

Reference:JCAO0404
Location: Galway
Qualification:Degree
Experience:3-4 Years
Job Type:Permanent
Salary:Not Disclosed
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Our client a high potential and well-funded medical device start-up company are currently seeking a Manufacturing Engineer to join their team. Reporting to a Director of Technical Operations the Manufacturing Engineer will work on aredeveloping innovative manufacturing solutions both in-house and at suppliers and manufacturing partner sites. The Manufacturing Engineer will also focus andapply knowledge of technical principles and systems/procedures to optimise manufacturing processes.


Role/Responsibilities

  • Full responsibility for the process development life cycle from ideation through to commercial validation.
  • Identify and ensure implementation of opportunities to optimize/improve manufacturing processes using engineering methods (e.g., SIX Sigma and LEAN methods)
  • Deploy the principles of KPI analysis, lean and six sigma in identifying and implementing the optimum areas for improvement in manufacturing operations
  • Work with internal team members to explore new technologies, assess in terms of performance, cost and reliability.
  • Employing technical skills to design and ensure equipment, tooling, 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).
  • Develop training and documentation materials (e.g., work instructions) for production to enable the seamless knowledge transfer of project and manufacturing processes.
  • Lead and establish project plans to ensure deliverables are completed to customer’s expectations, using project management tools (e.g., Project Plan, Risk Analysis, etc.).
  • Oversee manufacturing support tasks; give instruction to technicians on conducting tests; train technicians and provide feedback; and coordinate technician work.
  • Proactively identify areas where process and product improvements can be effected.
  • Develop predictive engineering tools, techniques and approaches in order to enhance operational processes.



Skills & Experience Required:



  • 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 with statistical techniques (DOE, Six Sigma).
  • Experience working with medical device lab/industrial equipment required.
  • Substantial understanding and knowledge of principles, theories, and concepts relevant to Engineering.
  • Good communication and presentation skills are desirable.
  • Thinks critically and makes sound decisions.
  • Collaborates and creates alignment as a team member/leader.
  • Experience and knowledge in Inventing, designing, optimizing verifying methodologies.
  • Knowledge of regulatory standards and design control systems desirable but not essential.
  • Collaborates and creates alignment as a team member



For further information please contact James Cassidy james.cassidy@lifescience.ie or call in confidence 086-0204322




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