Product Development Engineer
Scottsdale, Arizona, United States
At NeoLight, I contributed to the design and advancement of Class II medical devices, ensuring compliance with FDA and CE standards while optimizing processes for efficiency and reliability. Key highlights include:- Medical Device Design: Prototyped innovative neonatal devices, conducted risk analyses, and led verification/validation activities in alignment with ISO standards, from concept through development.- Validation Expertise: Executed equipment qualifications, process validations, and measurement system analyses, leveraging Gage R&R studies, DoE, and other SPC methodologies.- Process Improvement: Investigated failure modes using FMEA and root cause analysis tools (Fishbone, 5 Whys), implemented CAPAs, and reduced manufacturing labor through optimized test processes.- Packaging Design: Led a comprehensive packaging overhaul, creating engineering drawings in SolidWorks, collaborating with third-party testing facilities, and ensuring compliance and product integrity.- Labeling Innovations: Developed and validated labeling processes, including IQ/OQ procedures, and redesigned labels to meet stringent regulatory standards.- Cross-Functional Support: Authored manufacturing work instructions, trained operators, and managed engineering documentation to support product updates and acquisition initiatives.