Our client, a leading medical device company in Cork are currently looking to recruit a Project Manager for their site.
Project manages a cross-functional team of professionals and liaises with the Process Development Department to develop and successfully implement manufacturing processes, resources, materials and systems to drive speed to market, product quality, ease of manufacturability and reduction in cost when compared with existing product platforms.
Key Areas of Responsibility
- Operations lead for New Product Introduction programs, with specific focus on Project Planning, Product Quality, Cost minimisation, Capacity Analysis, DFM (Design for Manufacture), manufacturing process introduction & associated validation.
- Provides strong, capable leadership to the Project Team(s) encompassing of key professionals from Quality, Sterilisation, Production, Manufacturing Engineering, Packaging, Labelling, Materials, Logistics, Finance, Industrial Engineering, HR, Equipment Engineering, Facilities & EH&S to ensure new product launch deliverables are achieved. Assumes overall responsibility for assigned teams & operational deliverables.
- Collaborates closely with the Process Development Department & Value Stream to ensure that all new products and processes are introduced into production compliantly, on time, within budget and are operationally successful. Ensures no adverse impact on Quality, Service or Cost. Drives activities to mitigate adverse effects on process capacity & yield.
- Develops, communicates, tracks and executes detailed project plans. Reports accurate and timely project metrics/status to stakeholders as required
- Liaises with Quality & Regulatory Affairs to ensure all Quality System and appropriate regulations are met.
- Determines capacity requirements and implements solutions in support of Design & Process Validation builds and product launch activities.
- Drives implementation of Lean throughout the project phases through to launch.
- Develops quotes and costing information, driving standard cost to less than existing predicate platforms. Drives capital acquisition activity from specifying equipment, contract negotiation, installation and validation.
- Liaises with Logistics in driving shipping & sterilisation activities.
- Identifies and escalates unresolved obstacles to the success of the project. Leads resolution of problems that impede project progress.
- All other duties as assigned.
Qualifications Knowledge Skills
- Bachelor Degree in Engineering or Science discipline or equivalent required
- Minimum of 5 years project management experience in a regulated industry essential. Has demonstrated ability to successfully plan, prioritise, multitask and organise multi-disciplinary team(s) to successfully achieve large project deliverables
- Has applied knowledge of FDA & International medical device regulations
- Ability to lead, motivate and influence a cross-functional team that does not report directly to this position
- Strong communication and interpersonal skills
- Excellent analytical and problem solving skills
- Experience in process validation preferred
For further information on this Project Manager role in Cork please contact Deirdre Finnerty on 091730022 / email@example.com
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