Manufacturing Engineer - Waltham, United States - BlackTree Technical Group, Inc.

Description

• 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.

• 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