Our client a global provider of specialty medical devices are currently seeking an R&D Engineer to join their team on a 2 year contract. R&D Engineer will be required to lead the delivery of projects to maintain business continuity in areas such as complying with regulations; resolving product performance issues; sustaining supply chain continuity and Remediation of DHF Work related to products and components. This an exciting opportunity to join a growing team and gain fantastic experience
• Lead projects in the redesign or replacement of existing components/assemblies where applicable to improve quality and produce compliant products to relevant standards Interface with suppliers, Strategic Sourcing, R&D, Quality and Regulatory Affairs to deliver projects.
• For in house manufactured and purchased components, plan and lead the verification and validation activities for new/replacement and existing products and components.
• Individually deliver the development/improvement of products and processes using engineering principles on a Computer Aided Design (CAD) system, optimize them utilizing tools such as Design of Experiments (DOE), accomplish their evaluation through verification and validation, and assist in their implementation with appropriate controls and metrics.
• Perform product testing, create models and prototypes to prove out new designs and changes to existing designs.
• For both in house and purchased components, lead the transfer of parts, assemblies, documentation and processes from prototype stage, through pilot to production. Define specifications for the generation of products/processes including experimental activity specifications through production lifecycle for the Device Master Record as required. Manage supplier initiated changes as required to sustain supply chain following applicable standard operation procedures.
• Meet project objectives, milestones, and target dates. Update and review project progress on an as-required basis by supervisor.
• Interface with suppliers to obtain quotations, purchase components, and debug problems with production parts.
• Interface with purchasing and marketing to develop supplier agreements for components and/or new products.
• As requested, work with Quality and R&D personnel to lead investigation of product complaints to determine root cause and implement corrective action.
• Direct and/or execute the efforts of draftsmen, technicians, tradesmen, and lab personnel in the development of products, processes, test fixtures, equipment, test procedures and documentation.
• Lead and participate in design and technical phase reviews.
• Support regulatory submissions and clinical trials as required.
• Ensure projects are developed and documented compliant with the Quality System
• Adhere to and ensure the compliance of Teleflex’s Code of Conduct, all Company policies, rules, procedures and housekeeping standards.
• Bachelor of Science in Mechanical or Biomedical Engineering preferred; other technical disciplines considered
• 3-5 years previous experience in related field (e.g. medical device manufacturing and assembly, disposables manufacturing processes, plastics, automation) – may be offset by advanced degrees.
• Strong analytical, technical and problem-solving skills.
• Previous experience in design of medical devices preferred. Hands-on experience preferred.
• Effective verbal and written communication skills.
• Team player with good interpersonal skills.
• Proficient in Microsoft Office Suite and SolidWorks or equivalent modeling system; familiar with statistical analysis (Minitab) and computerized analysis (FEA) applications.