- Leads the design of new packages and improvement of legacy designs and manufacturing processes or serve as a key member on a project teams.
- Review and understand equipment specifications as supplied by equipment vendors. Management of capital projects from feasibility concept through installation and validation.
- Directs the generation of prototype samples to evaluate new materials and/or design concepts.
- Leads the Risk Analysis role for the package design, process design and process FMEA’s.
- Develops comprehensive validation plans generates protocol and reports.
- Manages collaboration across multiple international facilities.
- Identifies new technologies that will provide innovation and product differentiation.
- Support and manage as required Packaging Development related quality improvement initiatives.
- Coordination of internal and external/contractor resources to develop solutions required to solve complex engineering problems will be a primary focus
- Strong communication, teamwork and organizational skills are essential.
- A thorough understanding of ISO13485, ISO11607, 21 CFR 820 and Process Validation is a must.
- 3 - 5 years' experience in a Medical Device or other regulated industry
- Conducting feasibility studies to estimate product cost as well as analyze capital equipment, capacity, and capability requirements;
- executing equipment qualification and process validation projects
- developing and executing project plans and scheduling
- programming and troubleshooting processes and standards;
- working with rapid prototyping technologies.
- Must have a Bachelor’s degree or equivalent in Engineering or a related field, plus 3 years of experience in a manufacturing environment.
- 10% - 15%
For further information on this Senior Packaging Engineer role in Galway please contact Amanda Reynolds on 0860468858/ email@example.com
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