Matthew Kotok

About Matthew Kotok

A driven engineering team-builder who promotes collaboration to build and deliver world-class medical device products in the Life Sciences industries. I embrace diversity and encourage innovative thought to build eclectic teams that create world-class results. My current passion is to partner, develop, and integrate artificial intelligence (AI) solutions into the medical device manufacturing and packaging systems and processes. I believe that if you’re not already on-board, then you’re already behind.Career-long Life Sciences industry background spans medical device manufacturing, decontamination technologies, medical devices, medical disposables, pharmaceuticals, medical capital equipment, high-volume manufacturing automation involving automated assembly, automated testing, real-time data collection, robotics, AI vision inspection, machine vision, packaging, loading, labeling, welding, instrumentation, discrete manufacturing lines. Proven leadership in New Product Development, Research and Development, Systems Integration, Quality Management Systems and Engineering Team Management. Delivered new products and technologies to global markets. Well-versed in regulatory compliance, quality systems and contract manufacturing. Expertise: AI Documentation, Automated Assembly, AI Vision Inspection, Automated Packaging, New Product Development, Engineering Management, Project Management, Software Development, Continuous Improvement, Regulatory Compliance, Quality Systems, Six Sigma, Sterilization, VHP, FDA, 21CFR Part 11, ISO 13485, IMDRF/SaMD, GAMP5, cGMP, Verification, Validation, IQ, OQ, PQManufacturers: Collate AI documentation platform, Allen Bradley PLC and HMI; Rockwell Automation software; Cognex vision and AI vision; Keyence vision, bar code scanner and laser profiler; Inductive Automation, Ignition data collection; Fanuc robots, Collate AI platforms

Experience

1. Principal Engineer - Manufacturing Automation

   Bayer

   Jan 2020 — Present · Pittsburgh, PA, US

   In our Radiology - Sterile Disposables Manufacturing business unit, I’m tasked with defining, sourcing and integrating advanced artificial intelligence (AI) platforms and systems with our automation technologies and software applications in sterile disposables manufacturing and packaging systems. Founding member of Bayer’s Medical Device and Combination Products (MDCP) global engineering group.Currently supporting multiple high volume, low mix manufacturing and test engineering sites in the U.S. and Costa Rica.

Education

• University of Pittsburgh

  BSEE, Electrical Engineering

Skills

• Product Development
• Leadership
• Global Management
• Cross-Functional Team Leadership
• Continuous Improvement
• Instrumentation
• Engineering Management
• User Interface Design
• Design Control
• Decision-Making
• Program Management
• Coaching
• Manufacturing
• 21 Cfr Part 11
• Medical Devices
• Data Collection
• Management
• Organizational Leadership
• System Verification
• Communication
• Executive Leadership
• Product Management
• Automation
• Pharmaceutical Industry
• Business Process Improvement
• Customer Service
• Business Analysis
• Mentoring
• Lean Manufacturing
• Process Improvement
• Engineering
• Teamwork
• Project Management
• Project Planning
• Small Business Management
• Personal Development
• Time Management
• Computer System Validation