Permanent, hybrid role based in the NeuroHub, Model Farm Road, Cork City, Ireland
Project Manager - R&D
This position is responsible for project managing (scope setting, project planning, and execution) the implementation of manufacturing processes and supply chain systems to support new product development and commercial launch, ensuring timely delivery, budget adherence, and performance standards.
Within the medical device quality management system, this leader manages a cross-functional team of professionals, fostering collaboration and alignment, while interfacing with Commercial and Operational leaders to maintain organizational cohesion through stakeholder management.
This role requires independent judgment, professional expertise, and minimal supervision.
Key Areas of Responsibility:
1. Set manufacturing strategy for the project, 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. Lead and oversee the project team comprising Quality, Sterilisation, Production, Packaging, Labelling, Materials, Logistics, Finance, Industrial Engineering, HR, Process Engineering, Facilities & EHS, ensuring achievement of deliverables and operational success.
4. Collaborate with manufacturing site leadership during design development to ensure compliant, timely, and within-budget process implementation, meeting quality system requirements for product transfer to commercialization.
5. Develop communication plans to update stakeholders on project status across business forums.
6. Coordinate with Regulatory Affairs to align project strategy with regulatory requirements.
7. Support supply chain strategies and drive timely qualification of sourced components (PPAP) in line with QMS.
8. Determine demand and implement manufacturing capacity solutions for product development, validation, and launch activities.
9. Promote Lean Manufacturing principles throughout project phases.
10. Lead capital acquisition strategies, including cost determination, approvals, negotiations, and installation of equipment.
11. Identify and escalate obstacles, leading resolution efforts to keep projects on track.
12. Set project priorities, instill urgency, and utilize project management tools to ensure delivery.
13. Participate in resource selection, training, and performance appraisals, including temporary SMEs.
14. Perform other duties as assigned.
Qualifications/Knowledge/Skills:
* Bachelor's Degree in Engineering or Science, or equivalent; project management certification preferred.
* At least 4 years of engineering/project experience in a regulated industry, with proven ability to manage multidisciplinary teams and deliver projects.
* Knowledge of FDA and international medical device regulations.
* Leadership skills to motivate and influence teams on moderate complexity projects.
* Strong communication, interpersonal, analytical, and problem-solving skills, including risk management.
* Experience in process validation and implementing Six Sigma and Lean methodologies preferred.
* Proficiency in MS Office (Excel, PowerPoint, MS Project).
#J-18808-Ljbffr