Manufacturing Engineer

3 weeks ago


Waltham, United States BlackTree Technical Group, Inc. Full time

ESSENTIAL DUTIES The requirements listed below are representative of the essential duties required of the Sr Manufacturing Engineer. · 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. · Manage new product introduction and transition from product development to production. · Lead effort to transition manufacturing of subassemblies to contract manufacturer. · Act as the point of contact for resolving technical issues at the contract manufacturer and the production floor.

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 and or laser 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)

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