Job Code: INT30327
Job ID: 497509
Role: Manufacturing Engineer
Location: Reedsville, PA - Onsite

Description:

• 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.
• Expertise in PFMEA, Gage R&R, test system and manufacturing software validation for medical devices within the manufacturing environment.
• Ability to learn and adapt to QMS and work closely with Philips Engineering community on new validation methods and re-validation projects.
• Guide and participate in bug testing, identification, and problem solving

Qualification:

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