Job Description

Locations

• Carrigtwohill Anngrove North SEO, Cork

Skills Required

• engineering/project in a regulated industry essentialintermediate
• FDA & International medical device regulationsintermediate
• process validationintermediate
• delivering results through Six Sigmaintermediate

Required Qualifications

• Bachelor’s degree in engineering or science discipline or equivalent required. (degree in engineering or science discipline or equivalent required)
• PM role experience in engineering/project in a regulated industry essential. Has demonstrated the ability to successfully plan, prioritize, multitask and organize a multi-disciplinary team(s) to successfully achieve project deliverables. (experience)
• Has applied knowledge of FDA & International medical device regulations. (experience)
• Ability to lead, motivate, and influence a cross-functional team on moderate complexity projects that do not report directly to this position. (experience)
• Excellent analytical and problem-solving skills including risk management experience. (experience)
• Bachelor’s degree in engineering or science discipline or equivalent required. (degree in engineering or science discipline or equivalent required)
• PM role experience in engineering/project in a regulated industry essential. Has demonstrated the ability to successfully plan, prioritize, multitask and organize a multi-disciplinary team(s) to successfully achieve project deliverables. (experience)
• Has applied knowledge of FDA & International medical device regulations. (experience)
• Ability to lead, motivate, and influence a cross-functional team on moderate complexity projects that do not report directly to this position. (experience)
• Excellent analytical and problem-solving skills including risk management experience. (experience)

Preferred Qualifications

• Project management certification through an accredited organization (preferred). (certification)
• Experience in process validation (experience)
• Experience with delivering results through Six Sigma and lean methods (experience)
• Project management certification through an accredited organization (preferred). (certification)
• Experience in process validation (experience)
• Experience with delivering results through Six Sigma and lean methods (experience)

Responsibilities

• Delivery of the manufacturing element of new product programs, with specific focus on scope setting, project planning and management, product quality, budget management, product supply management, and DFM (Design for Manufacture).
• Provides strong, capable leadership to the project team encompassing key professionals from Quality, Sterilization, Production, Packaging, Labelling, Materials, Logistics, Finance, Industrial Engineering, HR, Process Engineering, Facilities & EH&S to ensure new product launch deliverables are achieved. Assumes overall responsibility for assigned teams and operational deliverables.
• Collaborates closely with leadership at the manufacturing site during the design development phase to ensure that all new manufacturing processes are introduced into production compliantly, on time, within budget, are operationally successful, and in alignment with the broader plant manufacturing strategy. Ensures all required quality management system deliverables are met by the team to effectively transfer the product into commercialization from the design development phase.
• Drives capital acquisition strategy through determining total capital expenditure and operational expense, acquiring internal approvals, supporting contract negotiations, and ensuring timely installation, qualification, and validation efforts.
• Develop a comprehensive communication plan and strategy to convey project status updates to stakeholders at both Commercial and Operational business forums.
• Liaises with Regulatory Affairs to ensure the project strategy is aligned with the required regulatory pathway and appropriate regulations are met.
• Delivery of the manufacturing element of new product programs, with specific focus on scope setting, project planning and management, product quality, budget management, product supply management, and DFM (Design for Manufacture).
• Provides strong, capable leadership to the project team encompassing key professionals from Quality, Sterilization, Production, Packaging, Labelling, Materials, Logistics, Finance, Industrial Engineering, HR, Process Engineering, Facilities & EH&S to ensure new product launch deliverables are achieved. Assumes overall responsibility for assigned teams and operational deliverables.
• Collaborates closely with leadership at the manufacturing site during the design development phase to ensure that all new manufacturing processes are introduced into production compliantly, on time, within budget, are operationally successful, and in alignment with the broader plant manufacturing strategy. Ensures all required quality management system deliverables are met by the team to effectively transfer the product into commercialization from the design development phase.
• Drives capital acquisition strategy through determining total capital expenditure and operational expense, acquiring internal approvals, supporting contract negotiations, and ensuring timely installation, qualification, and validation efforts.
• Develop a comprehensive communication plan and strategy to convey project status updates to stakeholders at both Commercial and Operational business forums.
• Liaises with Regulatory Affairs to ensure the project strategy is aligned with the required regulatory pathway and appropriate regulations are met.

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