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Sr. Manufacturing Engineer
154902
Posted:
14/11/2024
- 140000 USD - 160000 USD
- San Jose, United States
- Permanent
Why join our team?
Here, you’ll work with a team that is pushing the boundaries of medical imaging technology, directly contributing to life-saving innovations. This is an exciting opportunity to be part of a fast-growing startup where your contributions will have a direct impact on healthcare outcomes.
Desired experience
? 4 or more years of experience in the manufacturing of Class-II or III small
disposable devices in a Cleanroom environment.
? Experience in the manufacturing of diagnostic or therapeutic medical equipment
? Experience with component manufacturing processes (i.e. injection molding, plastic extrusions, machining, sheet metal etc)
? Strong understanding of product development and manufacturing processes in
accordance with GMP, FDA QS regulations, ISO 13485
? Proficiency in SolidWorks, MS-Word, Excel
Responsibilities:
? Work cross-functionally to transfer design of new or updated products to Production
? Develop manufacturing processes, process instructions, and testing instructions
? Create and maintain manufacturing tool/equipment drawings and manufacturing
documentation in coordination with the Quality System.
? Perform installation and qualification of manufacturing fixtures and/or equipment
? Create, review, and approve design change, and maintain accurate documentation of concepts, designs, and processes.
Education Requirements:
? BSME or related discipline
Here, you’ll work with a team that is pushing the boundaries of medical imaging technology, directly contributing to life-saving innovations. This is an exciting opportunity to be part of a fast-growing startup where your contributions will have a direct impact on healthcare outcomes.
Desired experience
? 4 or more years of experience in the manufacturing of Class-II or III small
disposable devices in a Cleanroom environment.
? Experience in the manufacturing of diagnostic or therapeutic medical equipment
? Experience with component manufacturing processes (i.e. injection molding, plastic extrusions, machining, sheet metal etc)
? Strong understanding of product development and manufacturing processes in
accordance with GMP, FDA QS regulations, ISO 13485
? Proficiency in SolidWorks, MS-Word, Excel
Responsibilities:
? Work cross-functionally to transfer design of new or updated products to Production
? Develop manufacturing processes, process instructions, and testing instructions
? Create and maintain manufacturing tool/equipment drawings and manufacturing
documentation in coordination with the Quality System.
? Perform installation and qualification of manufacturing fixtures and/or equipment
? Create, review, and approve design change, and maintain accurate documentation of concepts, designs, and processes.
Education Requirements:
? BSME or related discipline