Daniel George Email & Phone Number

Dallas, Texas, US

Dallas, Texas, US

• Lead Quality Engineer on the Digital Biomarker program encompassing Class II Wearables, AI/ML-driven algorithms and integrated mobile applications and accessories
• Functioned as the key Cybersecurity SME for medical device development, leading a comprehensive QualityManagement System (QMS) overhaul to ensure compliance to the latest FDA cybersecurity guidances
• Successfully navigated cross-functional engineering and clinical teams through the entire Product Development Lifecycle, facilitating multiple investigational clinical deployments
• Contributed to the development and qualification of critical non-device tools and Medical Device Data Systems (MDDS) that directly supported medical device success.
• Contributed to multiple NCR and CAPA investigations, corrective action identification and effectiveness reviews
• Provided essential support for multiple QMS certification audits and putting together regulatory submissions

Minneapolis, MN, US

• Lead Quality engineer for system accessories and Risk Management on portable hemodialysis machine projects
• Oversees product cybersecurity risk management activities in accordance with AAMI TIR57 and AAMI TIR97
• Collaborates with manufacturing and R&D functions to develop and implement quality processes and work instructions for an accessory pilot manufacturing line and creation of the associated DMR file
• Maintains System and sub-system DHFs and checks content for completion, integrity, regulatory & standards compliance; collaboratively communicating & resolving gaps.

Minneapolis, MN, US

• Responsible for reviewing and maintaining product risk management file, and lead risk management activities including Product Hazard Analysis and design and process FMEAs against ISO 14971
• Assisted in drafting of new business unit Design Control Procedures and templates to align with ISO 13485, as well as the associated impact assessment to the project regarding the various deliverables being adopted
• Supported Design Verification and Validation activities and ensures compliance with quality system regulations like FDA 21 CFR820 and ISO 13485, and additional internal requirements
• Supported the development, validation and implementation of Test Methods and Test Equipment
• Defined and developed user needs, business needs, system and sub-system requirements, and built the traceability between these various levels through use of requirements database PTC Integrity
• Collaborated with Sourcing and Supply quality to create and maintain a project-wide Supplier tracker and ensured key deliverables were met to add vendors to the Approved supplier list

• Driver Interface Group - Prof. Paul Green
• Developed and optimized MiniSim Driving Simulator to conduct research on driver behavior and workload
• Reviewed and authored technical report on Guidelines and Standards for Automotive HMIs
• Executed usability tests for a visual-display device in a simulated hospital environment
• Instructed and coordinated for the annual Human Factor short course

Esslingen, DE

• Appointed to the Quality Control Department and introduced to the various instruments and machines used
• Analyzed Lean manufacturing processes such as Kaizen, Kanban, JIT, Poka-Yoke and 6S methodologies
• Carried out Task and Risk analysis for certain operations in the productions line
• Performed sampling inspection of parts coming in from the vendors
• Evaluated incoming sample lots by visual inspection, profile measurement & roughness tests using various coordinate measuring machines, laser profile measurements and surface roughness testers

Doha, Qatar, QA

• Worked in Projects department, gaining knowledge on how a job is carried out from start to finish
• Tracked progress of various jobs and learned about the various manufacturing processes behind them
• Reviewed Quality and NDTs regarding dimensioning, welding, load testing, galvanization and painting
• Inspected and validated drawings of various jobs and selection of appropriate materials needed

Master Of Science (Ms), Mechanical Engineering

Bachelor Of Science (Bs), Mechanical Engineering