Development Engineer

John Pontius 720-***-****

***** ***** **** • Tustin, CA 92780 • *********@*****.***

Engineering Professional

Dedicated, resourceful, and energetic professional with a demonstrated record of manufacturing process development for Class III medical devices and Transcatheter Aortic Valve Replacement (TAVR) therapies. Track record of deploying innovative technologies and research to support scientific initiatives. Keen ability to collaborate across all organization levels. Hands-on leader with excellent communication, analytical, and problem-solving skills.

CORE COMPETENCIES

Creativity Fixture Design Prototyping Product Development Technical Writing Teamwork Solidworks Excel Minitab Statistical Analysis Matlab Image Processing with ImageJ IQ/OQ/PQ GR&R Good Documentation Practices Test Method Validation Human Anatomy & Physiology EDUCATION

Master of Science in Mechanical Engineering, Biomedical Engineering Concentration, May 2018 California Baptist University, Riverside, CA (3.87 GPA) Bachelor of Science in Biological Science, Biomedical Engineering Minor August 2015 Colorado State University, Fort Collins, CO

CAREER EXPERIENCE

JenaValve Technology Inc, Irvine, CA

Development Engineer August 2019 – Present

Responsible for manufacturing and process development tasks associated with the development and commercialization of transcatheter heart valves and delivery systems in cGMP and ISO regulated environments.

● Develop fixtures, workflow, protocols and work instructions for medical device manufacturing processes.

● Lead test method validation and equipment qualification by executing test protocols and test reports.

● Perform IQ/OQ/PQ on equipment and test fixtures.

● Collaborate with colleagues, technicians, vendors, and senior leadership across departments between domestic and international manufacturing sites.

Associate Development Engineer December 2018 – August 2019

● Conceptualize, develop, and implement fixturing and work instructions in compliance with standard operating procedures and quality systems.

● Travel to local vendors and manufacturing facilities based in the UK to drive process development and tissue characterization efforts to completion.

California Baptist University, Riverside, CA

Adjunct Professor, Department of Bioengineering August 2017 – August 2019 Administer courses to classes of university undergraduate students. Taught courses in Elementary Algebra, Introduction to Mathematics Engineering, and Engineering Physiology.

● Collaborate with colleagues and senior leadership across the Department of Bioengineering and Department of Mathematics to improve curricula and problem solve student concerns. PUBLICATIONS & PRESENTATIONS

J. Wang; J. Xi; P. Han; N. Wongwiset; J. Pontius; H. Dong. (2018). “Computational Analysis of a Flapping Uvula on Aerodynamics and Pharyngeal Wall Collapsibility in Sleep Apnea.” Journal of Biomechanics 94, 88-98. PROFESSIONAL AFFILIATIONS & AWARDS

Member, Device Alliance

Member, Biomedical Engineering Society

Servant Leadership Award, California Baptist University

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