- Develops processes and/or manufacturing equipment in support of medical device manufacturing.
- Projects are of moderate to high complexity, relating to bringing best in class medical devices to the marketplace.
- Under limited supervision/guidance, compiles, analyzes, and reports operational, test, and research data to establish performance standards for newly designed or modified processes and materials.
- Executes the functional deliverables associated with the process development process, project management, and quality systems.
- Ensures proper documentation is completed to meet quality systems requirements. (e.g., BOM’s, Routers, FMEA’s, etc.)
- Provides Design for Manufacturability (DFM) input to the engineering print package.
- Writes validation protocols and reports applicable to new processes.
- Oversees test builds associated with the project. Ideal candidate will have significant experience in several of the following areas: *polymer extrusion *solid modeling *tooling/fixture design *coating application *automation *microfabrication *UV bonding *polymer lamination *test method validation *insert molding *visual inspection *metrology *metallurgy *braiding
- B.S. degree in engineering or applicable technical field (mechanical or biomedical preferred), or A.S. degree with significant, relevant experience.
- 5+ years’ of experience in the medical device industry preferred
- Excellent interpersonal and communication skills with good leadership abilities.
- Excellent analytical and problem solving skills.
- Strong technical capabilities and project management capability to develop aspects of assigned projects on time and within budget.
- Viewed as a team resource.
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