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Contact Info
James Cassidy
Life Science

+353 1 5079250
[email protected]
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Details

Product Engineer


Reference:JCA02105 Location: Dublin
Qualification:DegreeExperience:4-5 Years
Job Type:PermanentSalary: Not Disclosed

Our client a medical device multinational currently seeks a Senior Product Engineer to join their R&D team on a 1-Year Fixed Term Contract


Role/Responsibilities

  • Lead the design, development and verification of medical devices and packaging throughout the development life cycle.
  • Utilizing best-in class project management practices, plan and execute sustaining engineering R&D projects which impact form/fit/function, business growth, cost reduction and compliance projects.
  • Plan and execute DV projects, managing product builds, preconditioning, transportation testing, accelerated and real time aging, product performance testing and associated reports & documentation.
  • Support the global roll out and commercialization of the portfolio. Be responsible for supporting effective design and technology transfer from development to manufacturing by proactively working with stakeholders from manufacturing.
  • Communicate project updates and escalations as appropriate to senior management and to cross functional stakeholders within the wider business unit.
  • Ensure compliance with all international standards and quality and safety regulations, policies, and procedures.
  • Collaborate with manufacturing plants to assist with product nonconformance issues and identify creative solutions to problems in a timely manner to process NC's and CAPA's.
  • Augment and maintain robust design history files for the current products and line extensions.
  • Plan and conduct ongoing competitive product analysis and device compatibility testing to provide key insights into the competitive landscape.
  • Design test equipment and create validated test procedures for product testing to demonstrate compliance with internal and external requirements such as ISO standards.
  • Manage, coach and mentor more junior team members as appropriate.

Skills/Experience
  • The successful candidate will be educated to degree level in Engineering with Mechanical, Design, Biomedical being preferred.
  • 7+ years’ experience in medical device design or R&D with a successful track record of delivering products to market and successfully supporting products in the market after launch.
  • Medical product design, research, and development.
  • High volume manufacturing.
  • Polymer material science and injection moulding processes.
  • Sustaining engineering activities post launch.
  • Tolerance analysis.
  • 2D drawing generation, GD&T.
  • 3D CAD modeling.
  • Fixture creation & development and test method development, implementation and validation (Gage R&R) for medical device/systems.
  • Statistical concepts such as those used in measurement system analysis (MAS), the design of experiments (DOE), and validation.
  • Quality management systems in a regulated environment.
  • The stage gate processes and design controls used in medical product development.


For further information please contact James Cassidy [email protected] or call in confidence 0860204322