Project Manager

• Lead the planning, execution, and delivery of new product development (NPD) projects within the medical device sector.
• Oversee product and process evaluation activities, ensuring alignment with quality and regulatory requirements.
• Coordinate the preparation of documentation for regulatory submissions in line with EU and US standards.
• Review and assess design outputs, driving effective design control and decision-making.
• Serve as the main point of contact for customers, providing updates on project milestones and progress.
• Establish and manage supply chains to support the transition from development to production.
• Coordinate the implementation of necessary tooling, equipment, and capital investments to ensure successful project delivery.
• Collaborate cross-functionally to ensure compliance with ISO 13485 and other relevant regulations.

• Degree in Mechanical Engineering, Biomedical Engineering, or a related discipline.
• Minimum of 5 years' experience in engineering design, product development, or a similar role.
• Strong ownership mindset with a track record of delivering projects from concept to completion.
• Proficiency in CAD tools such as SolidWorks, AutoCAD, or similar.
• Excellent communication skills and ability to work independently in a regulated environment.

Collins McNicholas