Sami Khalafallah
Belmont
Summary
Results-driven Quality Engineer with expertise in risk management and compliance at Johnson and Johnson MedTech. Proven track record in enhancing product quality through statistical analysis and process optimization. Skilled in CAD (SolidWorks) and adept at cross-functional collaboration, ensuring alignment with regulatory standards and improving operational efficiency.
Overview
5
5
years of professional experience
1
1
Certification
Work History
Quality Engineer, Robotics and Digital Solutions
Johnson and Johnson MedTech
Santa Clara
01.2022 - Current
- Spearheaded development of Risk Management Plan and Report for Bronchoscopy platform, conducting detailed risk analysis on 30+ DFMEA and PFMEA documents to ensure precise risk scoring and compliance with ISO 14971.
- Developed Component Criticality Assessment worksheets for new product introduction and sustaining projects, collaborating with R&D to assess part function, risk, and quality impact.
- Created over 50 Inspection Plans for hardware, instruments, and accessory components, ensuring alignment with design specifications and regulatory requirements.
- Reviewed system-level verification protocols, providing quality input to ensure thorough testing aligns with regulatory standards.
- Completed test method validation requirements by executing TMVA procedures.
Robotics System Testing Engineer
Johnson & Johnson MedTech
Redwood City
03.2024 - 09.2024
- Developed and executed Test Method Validation protocol, ensuring compliance with regulatory standards for Urology Robotic System.
- Collaborated cross-functionally with Systems Engineering to enhance protocol design and execution.
- Provided design input on test fixtures to improve repeatability and alignment with verification methods.
Business Process Automation Intern
Trumpf Inc
Farmington
09.2021 - 12.2021
- Supported the Manufacturing Control Department in transitioning to a digital manufacturing framework, developing tools and dashboards for improved communication with suppliers.
- Created simulation and predictive models to forecast production demands, ensuring optimal resource utilization.
Quality Engineering Co-Op
Parker Hannifin Corporation
New Britain
09.2021 - 12.2021
- Collaborated with cross-functional teams to analyze solenoid valve performance issues using Six Sigma methodologies.
- Increased product first-pass yield from 96.37% to 99.21%, significantly reducing scrap percentages.
- Applied statistical analysis techniques, including SPC, control charts, and MSA, to improve process efficiency.
- Proposed standardized procedures for operators to effectively track product rework and scrap.
- Created and updated control plans and PFMEA for existing processes, ensuring quality assurance.
- Utilized engineering inspection tools to evaluate product integrity and compliance with specifications.
- Developed a spring testing fixture that enhanced positioning accuracy and improved testing efficiency.
Graduate Research Assistant
ASOS Research Lab at University of New Haven
West Haven
09.2020 - 12.2021
- Developed stochastic optimization models and simulation prototypes using C++ within SIMIO software, enhancing manufacturing strategies through quantifiable data analysis to reduce cycle times and improve output efficiencies.
Education
M.S - Industrial and Systems Engineering, Concentration in Manufacturing Systems
University of New Haven
West Haven, CT12.2021
B.S - Mechanical Engineering, Concentration in Manufacturing Technology
University of Khartoum
12.2016
Skills
- CAD expertise (SolidWorks) and manufacturing processes
- Analytical and statistical skills
- Programming proficiency (Python, SQL)
- Knowledge of FDA regulations and ISO standards
- Verbal and written communication
Leadership & Activities
President | Institute of Industrial and Systems Engineers Student Chapter University of New Haven | December 2021 Organizing seminars, workshops, and networking events to enhance the professional competency of ISE students. Six Sigma Project | Improving of an Existing Paper Helicopter Design with DMAIC University of New Haven | December 2020
Professional Development
University of Pennsylvania, Certificate in Programming with Python and Java May 2025
Currently pursuing a four-course specialization in programming, focusing on foundational concepts in Python and advancing to object-oriented programming and data structures in Java, with the goal of developing fully functional applications in both languages.
Cornell University, Certificate in Interactive System Design (Mechatronics) Feb 2025
Completed a hands-on certificate program in designing and building interactive devices with Arduino and Raspberry Pi, acquiring expertise in electronics, programming, and networked communications to create user-friendly systems that enhance interaction and functionality.
Georgia Institute of Technology, Course in Machine Design (Material Science) Dec 2024
Completed Machine Design course, covering fundamental mechanical design principles, statics and fatigue failure theories, and analysis of materials and mechanical systems, including case studies on total hip replacement to illustrate material dynamics.
Certification
ASQ SSGB Certification
Affiliations
Robotics Developer at Hacker Dojo
Timeline
Robotics System Testing Engineer
Johnson & Johnson MedTech
03.2024 - 09.2024
Quality Engineer, Robotics and Digital Solutions
Johnson and Johnson MedTech
01.2022 - Current
Business Process Automation Intern
Trumpf Inc
09.2021 - 12.2021
Quality Engineering Co-Op
Parker Hannifin Corporation
09.2021 - 12.2021
Graduate Research Assistant
ASOS Research Lab at University of New Haven
09.2020 - 12.2021
M.S - Industrial and Systems Engineering, Concentration in Manufacturing Systems
University of New Haven
B.S - Mechanical Engineering, Concentration in Manufacturing Technology
University of Khartoum