Process Engineer Consultant //Manufacturing Engineer Consultant

Open to candidates who can travel to San Diego for the project (hence the 100% travel option)

Process Engineer Consultant I  
High-End/Specialty 
 Experience: Minimum 8 years professional experience in the applicable role. Education: Bachelor's /Master's degree in Engineering. Demonstrated capability and experience in role. 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 manufacturing environment. Ability to learn and adapt to Philips 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. oversees the validation process, the QMS system and participates in the Internal Quality Audits. Write and maintain FDA level validation protocols and reports. Support quality planning activities on new and existing programs. Investigate customer quality issues and requests. Interpret and implement ISO9000/13485 and FDA standards. Support internal audits. May require focus on CAPA execution in Operations. 
 Experience with all or some of the following manufacturing processes is needed: 
 PCBA incoming inspection, resistance spot welding, hand soldering, ultrasonic welding, RTV Application 
 
 or 
 
 Manufacturing Engineer Consultant II 
 High-End/Specialty 
 Experience: Minimum 15 years professional experience in the applicable role. Education: Education: Bachelor's /Master's degree in Engineering. Expert and technical lead with proven experience. 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 manufacturing environment. Ability to learn and adapt to Philips 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. 
 Experience with all or some of the following manufacturing processes is needed: 
 PCBA incoming inspection, resistance spot welding, hand soldering, ultrasonic welding, RTV Application 

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