CREGG are hiring a Project Manager to work within the Equipment Engineering team of a leading Medical Device company in Galway,
For more information contact Mark: or
The Project Manager within Equipment Engineering, is responsible for leading the planning, execution, and delivery of equipment-related projects that support medical device manufacturing and R&D. This role ensures that all equipment projects (new builds, upgrades, validations, and transfers) are completed on time, within budget, and in compliance with medical device regulations.
The Project Manager will collaborate with cross-functional teams (Engineering, Quality, Regulatory, Operations, and Supply Chain) to ensure robust equipment solutions that enable safe, effective, and compliant medical device production.
Key Responsibilities
* Lead project management activities for new equipment introduction, modifications, and transfers across global sites.
* Define project scope, goals, and deliverables in alignment with business objectives.
* Develop and manage detailed project plans, schedules, budgets, and risk registers.
* Drive equipment qualification and validation activities (IQ/OQ/PQ) in collaboration with engineering and quality teams.
* Ensure compliance with Good Manufacturing Practices (GMP) and regulatory standards.
* Coordinate with external vendors, contractors, and suppliers for equipment procurement and integration.
* Facilitate design reviews, risk assessments (FMEA), and technical documentation.
* Track and report project status, progress, and metrics to stakeholders and senior leadership.
* Lead problem-solving efforts to address technical or compliance challenges.
* Champion continuous improvement initiatives within equipment engineering and project management practices.
Qualifications & Experience
* Bachelor's degree in Engineering (Mechanical, Electrical, Biomedical, or related field); advanced degree preferred.
* 5+ years of project management experience, ideally in the
medical device, pharmaceutical, or regulated manufacturing
industry.
* Strong knowledge of equipment engineering, automation, and manufacturing processes.
* Proven track record in equipment validation and regulatory compliance.
* Proficiency with project management tools (MS Project, Smartsheet, or equivalent).
* PMP or PRINCE2 certification preferred.
* Familiarity with Lean, Six Sigma, or other process improvement methodologies desirable.