Project Manager

HR Duo; Limerick; Ibrido; EUR 70.000 - 100.000; Tempo pieno

Descrizione del lavoro

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.

Competenze

• 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.

Mansioni

• 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.

Conoscenze

PM experience

ISO 13485 knowledge

Communication skills

Stakeholder management

NPI/complex projects

Cross-functional leadership

Formazione

Third-level qualification in Engineering/Science/Business

Strumenti

MS Project

Smartsheet

Agile

Stage-Gate

Descrizione del lavoro

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