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.

This role is a 12 month contract role.

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