Manufacturing Engineer
4 weeks ago
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)
by Jobble
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