Permanent, hybrid role based in the NeuroHub, Model Farm Road, Cork City, Ireland
This position is responsible for project managing (scope setting, project planning, and execution) the implementation of manufacturing processes and supply chain systems to support the development and launch of new product programs on time, within budget, and to performance requirements.
Working within the medical device quality management system, this leader manages a cross-functional team of professionals, promoting collaboration and alignment while interfacing with Commercial and Operational leaders to maintain organizational harmony through stakeholder management.
This is an individual contributor role requiring professional judgment and the ability to work independently with minimal supervision.
Key Areas of Responsibility:
1. Set manufacturing strategy for projects, aligning with Commercial and Operational leaders.
2. Deliver manufacturing components of new product programs, focusing on scope, planning, quality, budget, supply, and Design for Manufacture (DFM).
3. Provide leadership to the project team, including Quality, Sterilisation, Production, Packaging, Labelling, Materials, Logistics, Finance, Industrial Engineering, HR, Process Engineering, Facilities & EHS, ensuring project deliverables are met and assuming responsibility for team and operational outcomes.
4. Collaborate with manufacturing site leadership during design development to ensure timely, compliant, and successful production process implementation, aligning with broader plant strategy and meeting quality management system requirements for product transfer to commercialization.
5. Develop communication strategies to update stakeholders on project status at various business forums.
6. Coordinate with Regulatory Affairs to ensure project strategies meet regulatory requirements.
7. Support supply chain strategies in collaboration with Global Quality & Operations, ensuring timely qualification of sourced components (PPAP) in line with QMS.
8. Assess demand and implement manufacturing capacity solutions for product development, validation, and launch activities.
9. Implement Lean Manufacturing practices throughout project phases to launch.
10. Drive capital expenditure strategies, including approvals, negotiations, and installation/validation of equipment.
11. Identify and escalate project obstacles; lead problem resolution efforts.
12. Prioritize project tasks, instill urgency, and utilize project management tools for successful delivery.
13. Participate in resource selection, training, and performance evaluations, including temporary SMEs.
14. Perform other duties as assigned.
Qualifications, Knowledge, and Skills:
1. Bachelor's Degree in Engineering or Science, or equivalent; project management certification preferred.
2. At least 4 years of engineering/project experience in a regulated industry, with proven ability to manage multidisciplinary teams and project deliverables.
3. Knowledge of FDA and international medical device regulations.
4. Leadership skills to motivate and influence teams on moderate complexity projects.
5. Strong communication, interpersonal, analytical, and problem-solving skills, including risk management experience.
6. Process validation experience preferred.
7. Experience with Six Sigma and Lean methodologies preferred.
8. High proficiency in PC skills, including MS Excel, PowerPoint, and MS Project.
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