Product Development Engineer

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JOB SUMMARY:

Come join our team at Medline ReNewal in Redmond, Oregon!  Our 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! https://www.youtube.com/watch?v=sNlLXZy-zK0. 

Our group is searching for a dynamic 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:

• Manage the design control process including investigation of product requirement/specifications, coordination of  verification and validation activities, coordination of design transfer activities and multi-source projects, determine performance impacts 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.

• 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.

MINIMUM JOB REQUIREMENTS

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.

Education

• Bachelor’s degree in Engineering or Science.

Work Experience

• At least 2 years of Product Development experience.

PREFERRED JOB REQUIREMENTS

• 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 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.