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Form of workJob Description
Education and/or Experience
· BS in Engineering or Science required.
· Minimum of 7 years' manufacturing experience; in the medical device/FDA regulated industry. Preferably in the capital equipment field.
· Prior experience working with contract manufacturing and transitioning products from design to contract manufacturing.
· Working knowledge of the FDA, ISO, and the medical device industry requirements (e.g., FDA QSR, ISO 13485, ISO 14971)
· Provide DFM and DFT feedback on new products as part of the development team.
· Create product workflows and routings.
· Create work instructions for internal and external use.
· Implement process and design improvements to improve cost, time, and quality.
· Develop, implement, verify, and validate manufacturing processes in support of process flow and value stream mapping improvements for existing and new products.
· Work with quality on verification and validation procedures to support the launch of commercial manufacturing.
· Enhance manufacturing process flow and floor layout to enhance safety, quality, and efficiency.
· Work with the product development team to design manufacturing tooling and fixtures.
· Work with production and quality on creating procedures and processes to manage external contract manufacturers as well as internal production.
