What are the responsibilities and job description for the Manufacturing Engineer position at Katalyst Healthcares and Life Sciences?
Responsibilities :
- Expert on manufacturing process flow and design transfer, Lead manufacturing fixture development, process development and qualifications, lead process development and optimization of critical fabrication.
- maintain manufacturing specifications, requirements, and Failure Modes and Effects Analyses (FEMA) in accordance with protocols and FDA guidance documents.
- expert technical lead on design transfer in partnership with contract manufacturers, conduct and lead failure investigations, ensure document management and manufacturing control compliance.
- conduct and manage structured design reviews. works with hardware, software and firmware engineers, user experience specialists and system engineers.
- guide and participate in test method validation, risk assessment, requirement development, protocol and validation report writing.
Requirements :
