Zachary Frey Email & Phone Number

United States

Virginia Beach, Va, Us

Cincinnati, Ohio, Us

Oversee development and implementation of manufacturing equipment and processes to maintain product functionality, quality, and cost efficiency.

Cincinnati, Ohio, Us

Researched, Selected, Designed, Developed, Implemented, Optimized, and Validated manufacturing processes and equipment for drug delivery and drug transfer systems to support clinical trials, design verification, and production operations. Technical leader and resource for manufacturing and cross-functional engineering projects. Project manager and team lead for clinical manufacturing and high-volume manufacturing scale-up activities.

Warsaw, Indiana, Us

New product introduction engineer for Trauma and Sports Medicine manufacturing. Developed new processes for 3D printed products and provided DFM and DFA feedback on design, manufacturing, and risk management strategy for new and existing projects. Supplier development and readiness, design transfer, test method validations, cleaning and sterilization validations for orthopedic implants. Implemented visual management and KPI metrics for continuous improvement activities.

Product Concept to Launch Project Management- New Product Design and Development Project Manager for medication management device, Manufacturing and Development Project Manager for cryogenic storage devices, Validation Project Manager for combination devices, Sustaining Project Manager for High Volume disposable product. Managed schedules, budget, cross-functional team, executive communication, risk management, supplier management, capacity analysis, resource planning and forecasting, capital equipment procurement.

MANUFACTURING ENGINEER- New Process and New Technology Development and Implementation for combination products, Process Optimization using Taguchi and Factorial DOE's, NDT Testing, Manual, Semi-Automated, and Fully Automated Clean Room Assembly, Sustaining EngineeringMECHANICAL DESIGN ENGINEER - Product Design for Manufacturability and Assembly, Gauge and Fixture Design including Electro-Mechanical Test Equipment Design and Semi-Automated Pneumatic Assembly Equipment Design, End of Line Testing for combination and medial products.PRODUCT DEVELOPMENT ENGINEER - Product Design Verification and Validation testing for combination devices. Product/component development for injection molded disposable devices and instruments.QUALITY ENGINEER - Test Method Validations, Equipment Qualification and Process Validation (IQ, OQ, PQ), Root Cause Investigation, Advanced Statistical Techniques, Quality Control Plans

Indianapolis, In, Us

Wrote and executed design verification protocols, designed engineering test and equipment, developed manufacturing processes and fixtures.

Chicago, Il, Us

Executed and evaluated design validation testing for bed products at the test lab using actual patients.

Marlborough, Ma, Us

Developed and Executed Engineering Test Protocols and Reports for Design Validation and Verification activities.

Designed new features and products for automotive and farming applications.

Master Of Science (M.S.), Engineering/Industrial Management

Bachelor’S Degree, Biomedical/Medical Engineering & Economics Minor