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.

• 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.