Medical Device Project Manager – NPI & ISO 13485

HR Duo; Limerick; Hybrid; EUR 70,000 - 100,000; Full time

Job summary

Croom Medical is seeking an experienced Project Manager to lead end-to-end NPI, capital investments, and process improvements within a medical device manufacturing environment. You will ensure regulatory and quality compliance while guiding cross-functional teams through stage-gate milestones.

You will work with ISO 13485 standards and contribute to DHF/DMR development during NPI activities, coordinating with Quality and Regulatory teams to maintain high standards.

Qualifications

• 5+ years PM experience in medical device manufacturing.
• Solid knowledge of ISO 13485 requirements.
• Experience delivering NPI or complex engineering projects on time and within budget.
• Strong communication and stakeholder management skills.

Responsibilities

• Lead end-to-end project management for NPI, capital investment, and process improvement initiatives.
• Develop detailed project plans with timelines, resources, risk registers, and budgets.
• Monitor and report project progress to senior leadership, escalating issues as needed.
• Ensure all deliverables meet regulatory, quality, and customer requirements.
• Support PM frameworks and tools within the organisation.

Skills

PM experience

ISO 13485 knowledge

Communication skills

Stakeholder management

NPI/complex projects

Cross-functional leadership

Education

Third-level qualification in Engineering/Science/Business

Tools

MS Project

Smartsheet

Agile

Stage-Gate

Job description

Croom Medical is seeking an experienced Project Manager to lead end-to-end NPI, capital investments, and process improvements within a medical device manufacturing environment. You will ensure regulatory and quality compliance while guiding cross-functional teams through stage-gate milestones.

You will work with ISO 13485 standards and contribute to DHF/DMR development during NPI activities, coordinating with Quality and Regulatory teams to maintain high standards.