Senior Project EngineerOur client a leading MNC in Parkmore, Galway is recruiting for a Senior Project Engineer Contractor. This position is responsible for planning, directing and coordinating concurrent projects/programs within the company’s Diagnostics division, in the Quality & Regulatory function. It is chiefly focused on governance, business and stakeholder engagement, scope management, change management, strategic planning, communications and project management through delivery.
The Project Management Specialist will work with the Senior Projects Manager in the Quality & Regulatory function, ensuring that the initiatives are aligned to the Division strategy and that projects are prioritized, funded and initiated. This role will interact with the Business Unit leaders, shared services leads and Division functional leaders. The role will be accountable for the execution of projects, within timelines and budget, and ensuring an achievable and successful outcome.
The role will be accountable for articulating and promoting the benefits of the programs and ensuring project plans are developed, maintained and risks escalated in a timely manner. The successful candidate will work closely with the entities within the Business Unit to ensure a well communicated project and hold regular project planning meetings with various sites/functions and divisional teams. The role shall be office based with travel expected, when necessary.
This job function has accountability for complying with the applicable elements of the Division Quality System procedures, and the Division project management methodology.
Responsibilities and Duties
- Carries out duties in compliance with established division’s policies and procedures.
- Demonstrates commitment to the development, implementation and effectiveness of applicable Quality Processes as per ISO, FDA, and other regulatory agencies.
- Responsible for exhibiting professional behaviour with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices.
- Responsibility to understand and maintain awareness of the quality consequences which may occur from the improper performance of their specific job.
- Perform duties and projects as assigned.
- Governance & Engagement: Sponsor’s engagement, project governance definition, initiative prioritization (incl. business cases), project planning and oversight, accountability, dependency mapping and coordination.
- Communications: Stakeholder mapping, expectations capture, communication plans, lead communication and engagement forums, involvement and sponsorship to initiatives and portfolio reporting.
- Scope and Business Change Management: project management and tracking, value/synergy realization, scope capture, change, impact & decision coordination, resource modelling/planning, transition planning and project coordination and execution.
- Support key areas of project management with on-going projects, in the areas of post market surveillance and compliant management.
- Fluent business English speaker with good interpersonal, excellent communication and presentation skills
- Minimum Bachelor’s Degree or equivalent qualification in a scientific discipline.
- At least 3 years’ experience in working through Project/Program Management, in Regulatory, Quality or Medical Device initiatives, with demonstrable evidence of effective execution and sustained compliance to regulations and standards.
- Experience in handling and delivering multiple projects (2 or more concurrently).
- Driven projects in a complex and multi stakeholder environment.
- Experienced in working with cross-functional teams such as Quality, Regulatory, Purchasing, Supply Chain, Finance, Marketing, etc.
- Experience of working with global teams with effective project execution.
- International exposure and experience, operating across multiple time zones.
- Experience of working with GMP compliant sites and achieved effective delivery with TPMs and in-house manufacturing sites.
- Familiar with ISO13485 quality system, EU in-vitro Diagnostics Regulation (IVDR) and EU Medical Device Regulations (MDR)
- Knowledge of MDR, IVDR, Post Market Surveillance, Vigilance, and Complaint processes a distinct advantage.
- PMP or equivalent certification in Project Management.
- Strong technology awareness in line with technologies in use across the Division (e.g. MS Projects, MS Office, MS Visio, SharePoint and MS Teams).
- Experience of leading and implementing change initiatives and active stakeholder management.
- Experience of working with culturally diverse groups of people, able to communicate effectively at all levels of the business, and with both technical and non-technical people, adapting approach to suit the audience.
- Attention to details by documenting meetings, action items and objectives.
For further information on this Senior Project Engineer role in Galway please contact Deirdre Finnerty on 086 3073779/ email@example.com
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