Permanent, hybrid role based in the NeuroHub, Model Farm Road, Cork City, Ireland
Senior Project Manager, R&D
Key Areas of Responsibility
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 launch. The role involves working within the medical device quality management system, managing a cross-functional team, and interfacing with Commercial and Operational leaders to ensure organizational alignment and stakeholder management.
This is an individual contributor role requiring professional judgment, working independently with minimal supervision.
Responsibilities include:
* Setting manufacturing strategy and gaining alignment with leadership.
* Delivering manufacturing components of new product programs, focusing on scope, planning, quality, budget, supply management, and DFM.
* Leading a diverse project team to achieve launch deliverables, assuming responsibility for team and operational outcomes.
* Collaborating with manufacturing site leadership during design to ensure timely, compliant, and successful process transfer and product commercialization.
* Developing communication strategies for project updates to stakeholders.
* Aligning project strategies with regulatory pathways and requirements.
* Supporting supply chain strategies and sourcing component qualifications.
* Determining demand and implementing manufacturing capacity solutions.
* Driving Lean Manufacturing practices throughout the project lifecycle.
* Managing capital expenditures and operational expenses, supporting negotiations and installations.
* Escalating and resolving project obstacles to ensure progress.
* Establishing project priorities and using management tools for delivery.
* Participating in resource selection, training, and performance appraisal.
* Performing additional duties as assigned.
Qualifications, Knowledge, and Skills
* Bachelor’s Degree in Engineering or Science, with project management certification preferred.
* At least 7 years of engineering/project experience in a regulated industry.
* Knowledge of FDA and international medical device regulations.
* Leadership skills to motivate and influence cross-functional teams on moderate projects.
* Strong communication, interpersonal, analytical, and problem-solving skills.
* Experience in process validation, Six Sigma, and Lean methodologies is preferred.
* High proficiency in PC skills, including MS Excel, PowerPoint, and MS Project.
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