Medline ReNewal is searching for a Product Development Engineer to lead all phases of the product development process for reprocessed single use devices, including developing new cleaning processes, performing testing, and preparing regulatory submissions.
Requirements
- At least 2 years of 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 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.
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.
Other
- Bachelor’s degree in Engineering or Science.
- The actual salary will vary based on applicant’s location, education, experience, skills, and abilities.
- This role is bonus and/or incentive eligible.
- We’re dedicated to creating a Medline where everyone feels they belong and can grow their career.
- We strive to do this by seeking diversity in all forms, acting inclusively, and ensuring that people have tools and resources to perform at their best.
