Team

Andrew Ozga

Senior Consultant

Andrew has been a Systems Engineer in the pharmaceutical industry for over 5 years. Throughout his career, he has developed well-rounded experience with systems engineering (ISO 15288), design controls (ISO 13485, 21 CFR 820.30), and risk management (ISO 14971). Andrew has leveraged his experience to drive the design and development of numerous drug-device combination products, including auto-injectors, injector pens, and enhanced prefilled syringes. Andrew is passionate about developing products that satisfy the needs of all stakeholders, including the patient, healthcare providers, business, and regulators.

Academic & Professional Qualifications:

  • Bachelor of Science in Physics, Butler University

  • Bachelor of Science in Mechanical Engineering, Purdue University

  • Certified Systems Engineering Professional, International Council on Systems Engineering (INCOSE)

Training, Quality Systems, & Specialties:

Core Competencies:

  • Stakeholder Needs and Requirements Definition
  • System Requirements Definition
  • System Verification and Validation
  • Technical Planning
  • Risk Management / Safety Engineering
  • Statistical Data Analysis

Standards and Regulations:

  • 21 CFR Part 820, Quality System Regulation
  • ISO 13485, Medical Devices – Quality Management Systems
  • ISO 14971, Risk Management
  • ISO 11608, Needle-based injection systems
  • ISO 11040, Pre-filled syringes
  • ISO 15288, System Life Cycle Processes