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James Cassidy
Life Science

+353 1 5079250
[email protected]
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Senior Manufacturing Engineer-Operations

Reference:JCAO1910 Location: Dublin
Qualification:DegreeExperience:5-7 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Senior Manufacturing Engineer

Senior Manufacturing Engineer Operations

Our client a medical device multinational are currently seeking a Manufacturing Engineer to join their team. As part of the Manufacturing Support team, successful canddiate will play a meaningful role in both executing manufacturing strategies and providing core sustaining engineering support and leadership. The Senior Manufacturing Engineer will support the operations team in assisting in developing strategies for existing and new products.


  • Development of Operations Strategies needed to support activities for the Injection Platform including but not limited to: Design for Molding/Manufacturing, Cost estimates, Capital requirements, Capacities, Technology, Architecture, Capabilities Analysis, and Materials Sourcing in a regulated industry
  • Support architecture and product development activities by providing operations leadership to the team by conducting analyses, giving technical support and recommendations of effective solutions to operational issues, product cost, and asset utilization
  • Develop, maintain and coordinate the tracking of major operational metrics (ie balanced score card, capacity utilization, waste and uptime pareto charts, value stream mapping) using an SAP/ERP environment and make improvements as needed to remain aligned to business needs and priorities
  • Lead project plans by collaborating with leadership in manufacturing facilities, the leaders within the company (Finance, R&D) and external suppliers/vendors
  • Provide a link between the Manufacturing sites, Product Development teams and the Process Development groups on new product development, including satellite design centers, on rapid prototyping, pilot line scale-up and process development, clinical and DV build capabilities


  • Bachelor’s degree or higher in Mechanical or related Engineering field is required
  • The candidate must have a minimum of 8 years proven experience, and knowledge in the fields of process development, manufacturing, and project engineering in a manufacturing plant
  • Strong project management and experience working with internal and external partners; including managing budgets (expense & capital), timelines, design scope and manufacturing activities
  • Experience developing equipment and processes for high volume manufacturing
  • Experience with ISO requirements and GMP guidelines, FDA regulations, medical device design control, and manufacturing scale up processes
  • Experience participating in multi-functional teams and NPD design transfer to manufacturing
  • Must be highly motivated with good organizational and analytical/technical problem-solving skills
  • Very strong and effective social skills with the ability to lead and develop others
  • Ability to manage competing simultaneous priorities effectively
  • Demonstrated understanding of process development considerations for tightly controlled, high-volume manufacturing designs & processes
  • Hands-on experience in the troubleshooting of machines and process operations for high-speed automation, including packaging
  • Excellent understanding of medical device product development risk management methodologies
  • Clear understanding and hands-on experience of product and process validation including V&V, TMV, FAI, FAT/SAT, IQ/OQ/PQ, etc
  • Solid understanding of Design of Experiments (DOE), Design for Manufacturing/Assembly (DFM/A), Measurement System Analysis (MSA), Gage R&R, and Design Control
  • Six Sigma, Lean and Continuous Improvement (CI) proficiency with experience in waste reduction
  • Experience managing capital budgets and project timelines
  • Demonstrated proficiency with data analysis and statistical techniques
  • Experienced SolidWorks, MS Office / Project / Visio user
  • SAP experience preferred.

For further information please contact James Cassidy [email protected] or call in confidence 0860204322