Project Manager

Croom Medical is a leading contract manufacturer of orthopaedic implants and instruments, headquartered in Croom, Co. Limerick. Operating to ISO 13485 quality management standards, we partner with global medical device companies to deliver precision-engineered products across our TALOS and Biofuse product platforms. With a growing team and expanding manufacturing capability, including our advanced ACOT facility, Croom Medical offers an exciting environment for experienced professionals to make a real impact.

Key Responsibilities and Duties

Project Planning & Delivery

• Lead end-to-end project management for NPI, capital investment, and process improvement initiatives
• Develop detailed project plans, including timelines, resource requirements, risk registers, and budgets
• Monitor and report on project progress to senior leadership, escalating issues and risks as appropriate
• Ensure all project deliverables meet regulatory, quality, and customer requirements
• Contribute to the development and improvement of project management frameworks and tools within the organisation

Cross-Functional Leadership

• Facilitate project meetings, design reviews, and gate reviews in line with stage-gate processes
• Build strong working relationships with internal stakeholders and external customers or suppliers as required

Quality & Regulatory Compliance

• Ensure all projects are executed in accordance with ISO 13485 quality management system requirements
• Support design history file (DHF) and device master record (DMR) development during NPI activities
• Work with Quality and Regulatory teams to ensure compliance with applicable standards.

Key Skills and Competencies

• Minimum 5 years' project management experience within the medical device manufacturing industry
• Proven track record of successfully delivering NPI or complex engineering projects on time and within budget
• Strong working knowledge of ISO 13485 quality management systems
• Proficiency in project management tools and methodologies (e.g. MS Project, Smartsheet, Agile, Stage-Gate)
• Excellent communication, presentation, and stakeholder management skills
• Third-level qualification in Engineering, Science, Business, or a related discipline