Staff Engineer - Katalyst Healthcares & Life Sciences
Santa Clara, CA 95050
About the Job
Roles & Responsibilities
- 8+ years of experience.
- Designing, developing, testing, validating, and implementing processes, tooling, and fixtures for CLIENT products.
- PAA remediation CAPA processing.
- Process development and or transfer to CLIENT Costa Rica manufacturing facility.
- Perform process gap assessments for existing commercialized product families.
- Lead and/or support efforts to develop and maintain process Failure Modes and Effects Analyses (pFMEAs) for company processes.
- Lead and/or support process/ product improvement projects, validation activities (IQ, OQ and PQ).
- Develop and maintain documentation for design control, product configurations (e.g., bills-of- materials), and other Quality System requirements.
- Provide sustaining manufacturing engineering support including, but not limited to, Client, line support, process development, etc.
Source : Katalyst Healthcares & Life Sciences
