Eakin Healthcare

Technical Project Manager

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Job Location

Newtownards, United Kingdom

Job Description

ABOUT THE ROLE Reporting to the Director of Development this is an exciting opportunity to build a key position within the R&D team. Central to the role will be delivery of core strategic and product development programmes that deliver the foundations to enable business growth, whilst exceeding customer expectations. The successful applicant will be required to plan and execute those programmes, with accountability for overall governance and reporting to senior leadership teams. KEY ACTIVITIES Coordinate cross-functional teams to deliver projects on time, within budget, and in adherence to quality standards. Develop comprehensive project plans, including resource allocation, risk assessment, and mitigation strategies. Foster collaboration among departments, including R&D, regulatory affairs, quality assurance, manufacturing, and therapeutic commercial teams, to optimize project outcomes. Alongside project technical leads, serve as the main contact between stakeholders, providing regular project updates to Project Sponsors, Senior Management and C-Suite as required. Monitor project progress, identify potential roadblocks, and drive solutions to maintain project momentum. Identify risks and coordinate mitigation strategies as well as conducting regular project risk assessments. Ensure compliance with medical device regulations, such as MDR, FDA and ISO13485, as required throughout the product development lifecycle. Promote a culture of continuous improvement and implement best practices in project management. Other To adhere to the companys Equal Opportunities policy and Dignity at work policy in all activities and to actively promote equality of opportunity wherever possible. To be responsible for your own health and safety and that of your colleagues, in accordance with the companys Health and Safety policy. To adhere to the companys Quality policy and Environmental policy. To undertake other duties as may be reasonably required. KEY SKILLS Essential Bachelor's degree in engineering or life sciences. Experience working within a project team within the medical device industry. Knowledge of medical device Product development processes and regulations, including FDA QSR, ISO 13485, and EU MDR. Ability to inspire and motivate cross-functional teams. Exceptional communication and interpersonal skills, with the ability to engage effectively with stakeholders at all levels. Desirable Evidence of successfully leading large-scale, complex Medical Device Development projects from initiation to commercialization Proficiency in project management tools and software KEY WORKING RELATIONSHIPS This role interacts across all of Eakin Healthcare and will have an influencing role with the following: Internal Clinical and Regulatory, Innovation, Development Commercial Operations to include Manufacturing, Facilities and Procurement Finance External Manage the outputs from: Key suppliers of equipment and components. Contractors and specialists such as Design houses & IT system suppliers. ]ADDITIONAL INFORMATION Able to travel frequently between our various locations and occasional international travel. Skills: Product Development ISO 13485 Continuous Improvement Project Management Cross Functional Collaboration Project Coordination

Location: Newtownards, GB

Posted Date: 11/29/2024
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Eakin Healthcare

Posted

November 29, 2024
UID: 4953801665

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