Role: MANUFACTURING ENGINEER

Location: REEDSVILLE, PA (ONSITE)

JOB 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) following protocols and FDA guidance documents,
• expert technical lead on design transfer in partnership with contract manufacturers, conduct and lead failure investigations, and 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 a Production Environment, ideally in FDA-regulated businesses.
• Firm understanding of IQ, OQ, PQ, and Software Validation requirements and practices.
• Expertise in PFMEA, Gage R&R, test systems, and manufacturing software validation for medical devices within the manufacturing environment.
• Ability to learn and adapt to Philips QMS and work closely with the 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 a closely related field