Medical Devices – Project Manager



Our client a medical device company are looking for a Project Manager with a Biomedical or Mechanical Engineering background to coordinate product development projects on their platform, between their teams in Ireland and other sites. The successful candidate will have excellent interpersonal and organisation skills and be fluent in English, allowing them to coordinate the activities of teams across multiple sites to deliver new projects.


Role/Responsibilities:

• Project planning to deliver project(s) against agreed milestones and project scope (schedule, resource, cost).
• Scheduling and driving project meetings.
• Allocating tasks and deadlines.
• Regular reporting on the project status, KPIs and project risks to the Programme Manager.
• Ensuring requirements and specifications are well defined.
• Integration of documentation into and maintenance of the design history file.
• Facilitation of good communication:
  • between our cross-functional teams in Ireland and the UK
  • with key stakeholders, external partners and vendors
  • to deliver project goals
• Planning and execution of verification and validation activities, including
  • Assisting in the generation of Validation Master Plans.
  • Assist with the planning/execution of Equipment Validations (IQs/OQs) and subsequently Design Verification and Process Validation (OQ / PQs).
• Support Regulatory Affairs with product submissions.

• Third level degree in Mechanical, Manufacturing or Production Engineering or similar discipline.
• Minimum of three years in product / process development, ideally in Class II / III medical devices in addition to two years minimum in a project management capacity.
• Strong interpersonal and team skills with ability to collaborate effectively and demonstrate conflict resolution.
• Solid planning and organization skills including attention to detail, multi-tasking, critical thinking and problem-solving skills.
• Skilled in preparing documentation such as project plans, schedules / timelines, checklists, protocols, and reports that are often detailed and complex.
• Comprehension of development/engineering principles, sufficient to allow participation in new product development or other projects.

• Certification from an accredited institution in Project/Program Management.(Desirable)
• Knowledge of medical device quality & regulatory systems and medical device directive (ISO13485, MDD and FDA CFR 820) and other pertinent Design Control requirements. (Desirable)
• Knowledge of anatomy and physiology of the brain (Desirable)
• Knowledge of manufacturing processes within a clean-room environment. (Desirable)