Project Manager Electronic Medical Device

Dublin 15 // Full Time // Negotiable
  • Production Manufacturing

My client is an international Pharmaceuticals and Medical Device manufacturer that has been managing complexity and improving lives since 1887 and distributing high quality drug delivery systems since early 2000. We offer a rewarding work environment with global opportunities while maintaining an employee-focused atmosphere. They are currently searching for a dynamic Device Engineering Project Manager to join our Global R & D Device Engineering team in Dublin.

 

Job Responsibilities:

  • The Programme Manager will provide leadership and centralized management for the planning, development and execution of technical projects to achieve critical strategic business objectives. Manages multiple, often concurrent projects and consistently meets expectations.
  • You will be fully competent in making difficult decisions regarding priorities among projects / programs while ensuring the buy in of teams and leaders
  • The Programme Manager will have responsibility for all phases of project execution including stage gate reviews, design reviews, etc.
  • You will lead the project team members in using established PM tools and techniques to stay within authorized budget limits and achieve the overall project / program and organizational objectives.
  • Must Competent in conducting risk assessments for technical and project related issues and developing mitigation plans to ensure project schedule and costs are maintained
  • The programme Project Manager will be an Innovator and forward thinker. Leads and contributes to the development of R&D organisation thru innovative thinking and application of technical knowledge.
  • Develop methods, procedures and metrics for projects (scope, schedule, quality and cost) and reporting. Monitors and controls implementation plan in accordance with defined scope
  • You will demonstrate responsible for the successful execution of significant technical projects. Through proper planning, ensures that scope, schedule, cost and customer expectations are met. Maintains a clear focus on life cycle costs
  • A technical / engineering background in new product development and sustaining engineering within the medical device sector.

 

  • Fosters an environment of innovation in others, integrating experiences from multiple disciplines to develop solutions that meet the business objectives.

 

  • Strong understanding of medical device regulations including FDA standard 21 CFR Parts 801 and 820, design controls, ISO13485, regulatory audits and international environmental regulations. Extensive experience and track record of success in the development of 510K/PMA regulated products required.

 

Job Requirements:

  • A minimum of 5 years’ experience and a proven track record in:
    • Applying project management tools to manage New Product Development Programs
    • Applying project management tools to manage Sustaining Engineering Projects
    • Building, managing and maintaining business partnerships
    • Applying knowledge of ISO standards and FDA Design Control regulations

 

  • Experience in development of complex sophisticated software controlled electromechanical medical devices with verification & validation activities is a plus.

Experience in development of complex sterile disposable medical devices including plastic injection molding, extrusion and assembly methods is a plus

Experience in outsourced medical device manufacturing, manufacturing technologies and process development is a plus

BS in engineering or technical field with 3+ years of new product development (medical device engineering) and 3+ years of applicable project or program management experience in medical devices, healthcare or pharma development environment.

Possesses interpersonal skills to negotiate and reconcile differences, while optimizing overall business goals

Excellent written and verbal communications skills with strong competency in MS Office tools and Project management applications.

Certification in Process Excellence (Green Belt or Black Belt) or project management certification PMP is a plus.

 

Education Preference:

  • BS in engineering or technical field with 3+ years of new product development (medical device engineering) and 3+ years of applicable project or program management experience in medical devices, healthcare or pharma development environment.

 

If you meet the criteria outlined above and are interested in a new exciting and rewarding career within a team of high performing programme managers, then please send your CV on total confidence to shane.gleeson@cpl.ie  and we can arrange to discuss the role further.

 

I am also contactable on 0867948141 from 9am to 7pm Monday to Friday.

My client is an international Pharmaceuticals and Medical Device manufacturer that has been managing complexity and improving lives since 1887 and distributing high quality drug delivery systems since early 2000. We offer a rewarding work environment with global opportunities while maintaining an employee-focused atmosphere. They are currently searching for a dynamic Device Engineering Project Manager to join our Global R & D Device Engineering team in Dublin.

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Job Overview

  • JO-1907-433931
  • Shane Gleeson
  • July 12, 2019
  • Dublin 15
  • Negotiable
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