Job Description
Job Description SummaryAs the R&D Engineer, you will support Sustaining Engineering activities for medical devices. Performing hands-on testing in optimisation of the device, conduct process development activities to understand process inputs and outputs. Assist and write technical documents, validation protocols and reports, prepare work instructions and standard operating procedures. You will participate with conducting design and process qualification and validation, support equipment development and other activities from R&D, Quality, Operations, and Regulatory Affairs.Main responsibilities will include:Designs, develops and implements product and process improvements of a medical device, translating intangible design inputs into tangible engineering specifications and drawings.Select appropriate materials, processes and vendors to achieve the design and challenge these designs against design specifications, clinical use scenarios and international standards.Plans, coordinates and builds test parts for engineering evaluation, pre-clinical studies and clinical studies.Makes and presents engineering decisions.Process Development: Develop new processes by understanding key process inputs and outputs, using statistical methods such as DOE as appropriate.Develops new process equipment and tooling, including specification development, vendor selection, and negotiation.Documentation: Prepare work instructions and standard operating procedures (SOP), write technical documents and reports. Prepare raw material specifications, drawings, verification and validation protocols, and reports.Test Method Development: Develop new engineering test methods and clinically relevant simulated use test methods in conjunction with R&D technicians; prepare and assist in validating test methods.Testing: Perform lab bench testing, conduct engineering and competitor evaluations, and conduct development unit testing. Plan, develop, coordinate, and execute verification and validation activities for new products and processes.Train technicians on new design and process development as well as new test methods. Conduct new process development training with operations and quality assurance in conjunction with R&D technicians.Supervisory/mentoring/coaching: Mentor/coach R&D engineers or technicians through New Product Development or Change Control Process activities.Participation in creating and controlling a project budget (expense and/or capital expenditure). Create and critique engineering cost analysis.About youRelevant Bachelor's Degree - Preferably in Mechanical or Biomedical Engineering. 5+ Years of Experience and proven track record in a similar role. Support Manufacturing, Quality, Regulatory & R&D to ensure systems align with all internal and external guidelines. Support/lead design, process root cause analysis, and support non-conforming product and complaint investigations. Experience within the Regulation Requirements (FDA/MDD/MDR).Click on apply if this sounds like you! #J-18808-Ljbffr