With fifty years of consecutive growth, Medline Industries has more than 25,000 employees worldwide and business in more than 90 countries. The Product Development Engineer position is a hybrid position that will be based out of our Medline ReNewal facility located in beautiful Central Oregon. To maintain this enviable position and continue our growth, we are looking for new talent, like you! Medline ReNewal is a single use medical device (SUD) commercial reprocessor. We collect used SUDs from healthcare facilities nationwide at our newly commissioned facility in Redmond Oregon and remanufacture them to meet or exceed the performance specifications of a new original equipment device. Watch this quick video to learn more: https://www.youtube.com/watch?v=LsdpSjd1fYs&feature=youtu.be Our Product Development Engineers, following guidance from the FDA, develop validated production processes that enable the disassembly, cleaning, disinfection, functional testing, repackaging and sterilization of SUDs. The result is a reprocessed SUD that provides the highest level of patient care, reduces medical waste, and is sold for half the price of a new device. Our engineers are eager problem solvers that use common sense with a hands-on approach when providing solutions. Here are some of the job duties: * Participate in development projects following established FDA design control procedures; from feasibility through production implementation, and release to market phases. * Develop and execute validation strategies for medical device cleaning, biocompatibility, functional performance and packaging studies that challenge the status quo. Write protocols, validation plans, procedures, analyses and reports. Create and maintain the design history file (DHF) and any other records created as part of the development efforts. * Work with multidisciplinary project teams to ensure projects meet established schedules. May serve as the project lead to direct activities related to product development. * Develop and write Standard Operating Procedures (SOP's) for processing devices in production. * Engage outside contracting services in support of project needs, i.e. analytical laboratories, consultants, material suppliers and equipment suppliers. Build effective relationships with these resources to meet delivery and budgetary goals. * Effectively communicate cross-functionally within the organization with teammates in: Manufacturing, Quality, Product Management, Marketing, Sales, and Regulatory. * Research and understand device functionality, device patents, and clinical use. Required Qualifications: * Bachelor's degree in an Engineering discipline * At least 2 years engineering experience * Technical writing, research paper writing, and/or experimental design experience * ERP systems knowledge and experience * Intermediate skill level in computer and systems use (Microsoft Word, PowerPoint, and Excel) Preferred Qualifications: * Bachelor's degree in Mechanical, Electrical or Biomedical engineering. * Prior experience working with medical devices; development, reprocessing and/or manufacturing * Prior experience working in a FDA regulated industry/field, or similar * Exposure to the FDA 510(k) process or other regulatory submissions * Experience measuring, conducting testing functions, interpreting and performing test procedures, operating testing equipment and creating/documenting test procedures and results. * Prior experience in a LEAN Manufacturing/Production environment, GMP and/or New Product Development * Prior design experience in CAD using SolidWorks * Prior experience reading and interpreting standards and guidance documents COVID-19 Vaccination Please be aware that Medline requires all employees starting in this position to be fully vaccinated against COVID-19. This position will require the successful candidate to provide proof that they are fully vaccinated by their start date. Medline is an equal opportunity employer, and will provide reasonable accommodations to those individuals who are unable to be vaccinated for COVID-19 consistent with federal, state, and local law. Medline offers a business casual, entrepreneurial work environment with strong growth potential, a competitive compensation package, and a complete benefits package including medical/dental/vision/life insurance; 401(k) with company match. And much more! Primary Location US-OR-Redmond https://www.linkedin.com/jobs/view/2903250077/?refId=Po1kFbrMRz2mdOgeF1wvuw%... Josefine Fleetwood, (she/her) Employer Relations Manager Oregon State University | College of Engineering 116 Johnson Hall - Room 112 541-737-7286 Josefine.fleetwood@oregonstate.edu<mailto:Josefine.fleetwood@oregonstate.edu> [cid:image001.jpg@01D81844.E7408E40]
