Contact: Anne - Marie Fox
Telephone: 087 2197421
Project Manager - NPI - Contract
Our client, a medical device company in Cork are currently looking to recruit a Project Manager for their site on a contract basis.
- Project planning to deliver projects against agreed milestones and project scope (schedule, resource, cost).
- Scheduling and driving project meetings to achieve objectives.
- Allocating tasks and deadlines.
- Regular reporting on the project status, performance and risks to the Engineering Team Leader.
- Ensuring requirements and specifications are well defined.
- Identify appropriate resources and requirements
- Facilitation of effective communication between our cross-functional teams, key stakeholders, external partners and vendors
- Facilitate design for manufacture reviews with technical SME support to minimize lifecycle cost
- Planning and execution of verification and validation activities, including:
- Assist with 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).
- Provide timely and accurate reporting on project activities.
- All employees are responsible for minimising both the Environmental and Health & Safety effects of the work that they perform.
- To adhere to the company’s procedures as detailed in the SOP manual.
- Liaise with existing or new suppliers (request for quotes, manufacture of parts etc).
- Support Regulatory Affairs with product submissions.
- All other duties as directed by direct manager.
- Third level degree in Mechanical, Manufacturing, 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.
- Flexible work ethic.
- 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
For further information on this Project Manager role in Cork please contact Anne - Marie Fox on 087 2197421 / firstname.lastname@example.org
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