Zachery Dusterhoft

Zachery Dusterhoft
Minneapolis, Minnesota
Mechanical Test Engineer|Medical Product Development|Design Verification|Test Method
Development|Verification|FDA|ISO|

Summary
Mechanical Test Engineer|Medical Product Development|Design Verification|Test Method
Development|Verification|FDA|ISO|

•zach.dusterhoft@outlook.com

DELIVERING PROJECT EXCELLENCE, DRIVING RESPONSIVE PRODUCT DEVELOPMENT
SUPPORT
Technologist with a track record of meeting and exceeding expectations in new product development
including R&D, testing, and transition to manufacturing in compliance with regulatory requirements.
Nationally registered Engineer in Training.
EXPERIENCED TECHNOLOGICAL INNOVATOR
• Test Method Protocol Development, Validation, Verification, Qualification, IQ, OQ & PQ.
• Design, manufacturing & sterility assurance of Class I, II, & III Medical Devices.
• Developing testing devices, processes and standards.
PROFICIENT ENGINEERING CONSULTANT AND SUBJECT MATTER EXPERT
• Adherence to ISO, FDA, RoHS, ASME, ASTM, ANSI, etc.
• Gage R&R, DOE, FMEA, Fish-bone root cause analyses, design verification’s, bio-compatibility
studies.
• Test method validation protocol development, etc.
• Time and cost management, task prioritization to meet or beat deadlines.
• Managing & adhering to internal and external, contractual, documentations
• Quoting and forecasting test plan resources for characterization testing, ageing studies, and design
verification testing.
• Analyzing information & data for technical, business and formal project decisions,
• Leading product development including design reviews where team members responses are crucial
in meeting strict product specifications, timelines and budgetary constraints.

I have a knack for meeting with customers, listening to their needs and providing them with timely
and cost effective solutions. Similar to software development, personally and professionally I’m in a
permanent beta phase, constantly iterating and improving.
Experience
Test Engineer II at Phillips-Medisize
July 2015 – Present (3 years 3 months)
•Performed Gage R&R and test method validation on test methods including fixtures and
equipment.
•Created test methods, test protocols, and test reports based on customer requirements.
•Lead and participated in weekly customer meetings, updating them on the status and progress of
their project.
•Participated in device design reviews.
•Verified and tested various medical device components and functionality.
•Designed test fixtures with 3D CAD models to test new product components and assemblies.
•Served as a lead contact on characterization testing for new customer products.
•Worked on design verification testing on injectable devices, inhalers, fluid pump systems, and
medical inserters.
•Familiar with FDA 21 CFR 820 Quality and Regulatory Requirements / ISO 11608.
•Lead root cause investigations and created documented deviations on various device failure
modes.
•Wrote and conducted equipment and software validation protocols for IQ/OQ/PQ

Material Engineering Intern at Marvin Windows and Doors
2012 – 2014 (2 years)

Meat Cutter at Hugos Family Market Place
2009 – 2013 (4 years)

Education
The University of North Dakota
Bachelor’s Degree, Mechanical Engineering, 2008 – 2014
Activities and Societies: UND Observatory Member 2009-2011
Zachery Dusterhoft
Minneapolis, Minnesota
Mechanical Test Engineer|Medical Product Development|Design Verification|Test Method
Development|Verification|FDA|ISO|