- Manage the design control process including investigation of product requirement/specifications, coordination ofverification and validation activities, coordination of design transfer activities and multi-source projects, determine performanceimpacts and process change of new materials and designs, conduct risk assessment activities, and resolve residual risk.
- Develop cleaning processes for reprocessed single use devices. Work with manufacturing engineering to implement processes into production environment.
- Research and understand device functionality. Utilize information to build validation test plan for medical devices. Complete validation studies in compliance with FDA/ISO standards.
- Collaborate with regulatory affairs on regulatory submissions. Provide technical input and support throughout submission review and process.With regulatory affairs support, navigate medical device standards and regulations in order to determine appropriate verification and validation paths for reprocessed single use devices.
- Work cross-functionally with manufacturing engineering, quality assurance, regulatory affairs, production, purchasing, warehouse, IT, and product management to bring new products to market.
- 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 goals. Manage technical work being completed by suppliers.
- Serve as a subject matter expert and utilize expertise to mentor and coach other members of the engineering staff.
- Communicate with senior management to remove barriers/obstacles that could impair the project's timeline and/or overall success.
- Bachelor's degree in Engineering or Science.
- At least 4 years of product development experience.
- At least 6 years of medical device product development experience
- Experience in the development and launch of new medical/pharma products.
- Experience with medical device requirements (Class I-II), design controls, risk assessments, and the 510k process. Experience with project management and Microsoft project.
- Experience with project management and communication software such as Asana.
- Experience utilizing Minitab to perform analysis of test data.
- Experience with CAD systems, FEA, Six Sigma, ANDA, ISO/CE Mark, GLP, GMP, GDP, USP testing, and high volume manufacturing processes.
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Sr. Product Development Engineer - Redmond, United States - Medline Industries
Description
JOB SUMMARYCome join our team at Medline ReNewal in Redmond, OregonOur custom-designed production facility is a great place to work and offers employee-friendly perks and benefits.To learn more about us, check out this video on YouTube
Our product development team is searching for a dynamic Sr Product Development Engineer to be responsible for leading all phases of the product development process for reprocessed single use devices. As an engineer with Medline ReNewal, you will develop and execute testing on reprocessed single use devices and work alongside the team to solve complex technical problems. The ideal candidate will use critical thinking and ingenuity to develop new cleaning processes, perform testing, and work closely with regulatory affairs to prepare regulatory submissions.
MAJOR RESPONSIBILITIES
Education
