Project Manager-Medical Device. Dublin
Our client are looking for a Project Managerwith a Biomedical or Mechanical Engineering background to coordinate product development projects on their Drug Delivery platform, between teams in Ireland and the UK.
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.
- 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, performance and 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:
o between our cross-functional teams in Ireland and the UK o with key stakeholders, external partners and vendors
o to deliver project goals
- Short term production and supply chain management
o Generation and updates to Bills of Material.
o Raise and manage engineering change documentation. o Create and modify Quality System documents.
o Liaise with existing or new suppliers (request for quotes, manufacture of parts etc).
- Planning and execution of verification and validation activities, including:
o Assisting in the generation of Validation Master Plans.
o 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.
All applicants must possess the following:
- 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.
Although not essential, it is desirable if applicants have the following:
- Certification from an accredited institution in Project/Program Management.
- Knowledge of medical device quality & regulatory systems and medical device directive (ISO13485, MDD and FDA CFR 820) and other pertinent Design Control requirements.
- Knowledge of anatomy and physiology.
- Knowledge of manufacturing processes within a clean-room environment.
- Must be a motivated and enthusiastic individual.
- A self-starter capable of planning and managing their own responsibilities with little input.
- Be a team-player that can develop strong working relationships within a cross-functional team (R&D, Purchasing, Finance, Engineering, Quality and Operations)
Based in Dublin plant. The role will involve some travel to our headquarters in the UK.
Contact Interested candidates should forward their CV to firstname.lastname@example.org immediately or call Robert Smith on +353 1 632 1200 for further information.