As a Manufacturing Engineer, you’ll support the development, production, and commercial launch of medical devices. You’ll review designs/prints in both the development and production phases to assure effective use of DFM/DFA/DFI. These reviews require interaction with cross-functional teams within Development/Design Engineering, Quality Engineering, QC/metrology, Programmers and Machinists to create designs and drawings that can be manufactured efficiently with a high confidence of product meeting specifications.
- Create and layout all phases of new product development from concept layout to production.
- Collaborate with teams across the organization, including Clinical Advisors, Marketing, Purchasing, and Engineering to create formal product specifications and decisions based upon input specifications
- Work effectively with peers within Development teams to achieve project objectives.
- Interface with vendors on technical issues and work to resolve issues
- If applicable, experience and project creative engineering drawings, including assignment of dimensions and tolerance to designs
- Support all engineering documentation activities related to product development, validation, launch, and production
- Assemble and troubleshoot prototype and production products
- Create and maintain documentation relevant to design control and other applicable regulatory requirements
- Understand basic anatomy and physiology of the spine and procedures for which products will be designed and developed
- Perform duties in compliance with applicable FDA and state regulations as well as standards including, but not limited to, ISO 13485