Manufacturing Engineer - Katalyst Healthcares & Life Sciences

• 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.

• Maintain, Validate and Release Test Systems in Production Environment, ideally in FDA regulated business.

• Firm understanding of IQ, OQ, PQ and Software Validation requirements and practices.

Requirements:

• BS/BA degree in Management, Operations, Engineering or closely related field.

• Expertise in PFMEA, Gage R&R, test system and manufacturing software validation for medical devices within manufacturing environment.

• Ability to learn and adapt to Client QMS and work closely with Client Engineering community on new validation methods and re-validation projects.

• Guide and participate in bug testing, identification, and problem solving.