Role: Sustaining / Process Engineer Company: AngioSafe Location: San Jose, CA Position Type: Full-Time on site
Roles and Responsibilities: - Primary focus is supporting the manufacturing line & advancing the processes and devices to support scale up.
- Create and document new manufacturing processes as necessary for production at significantly higher volumes and validate as appropriate.
- Support ongoing manufacturing activities including dealing with production equipment, non-conformances, facilities and other line related issues.
- Spending significant time on the manufacturing line alongside the assemblers to improve processes and increase quality; primary interface between engineering and production.
- Assist development of assembly and test fixturing with a focus on quality and volume.
- Write protocols & test reports related to validation activities.
- Collaborate with existing suppliers to improve manufacturability and decrease cost.
- Qualify components from new suppliers to improve supply chain flexibility.
Skills, Experience, & Behaviors: - Solid history of experience in medical device manufacturing environment, roughly 5 years preferred
- Strong preference for lamination, laser welding and UV curing expertise
- Proven experience editing MP's, LHR's, BOM's etc.
- Demonstrated comfort using inspection & test equipment (vision systems, tensile testing)
- Ability to work within & maintain compliance to highly regulated environment
- Demonstrated ability to work independently
- Flexibility and willingness to take on a variety of roles in a small company
- Demonstrated ability to collaborate effectively, especially with team of diverse assemblers
- Strong verbal and written communication skills
No relocation or immigration support provided for this role.Principals only Please
