Jennifer Headley Email and Phone Number

Cardiovascular Portfolio - Cardiac Ablations Solutions

Neuroscience Portfolio - Cranial and Spine Technology

Restorative Therapies Group - Enabling Technologies

Identify and understand clinical and market needs worldwide, develop winning product strategies, and ensure products' fitness for use. Interact with colleagues in a variety of disciplines, including engineering, manufacturing, biological sciences, clinical medicine, regulatory, legal, business, marketing, and sales. Serve as the primary interface between customers, sales and marketing associates, and leadership associates for the products supported. Focus on device fitness for use – ensuring device safety and efficacy. Influence manufacturing and operations on commercially released products to ensure product supply and quality. Develop and lead product training for physician customers and field sales associates.

Responsible for executing all fatigue related activities for structural heart business unit. Including setting overall fatigue design evaluation strategy, creating new in vitro fatigue test methods, quantify fatigue life boundary conditions, establishing constant life diagrams for new materials, acting as a contributing scientist on in vivo animal studies, and providing technical rationales. Established deep knowledge of the quality system and regulatory function via extensive interactions supporting the regulatory process during IDE and PMA submissions. Activitiesincluded submission reviews, authoring answers to deficiency questions, supporting FDA conference calls and an on-site presentation to the FDA. Started field visit program to help engineering associates gain knowledge of the clinical setting and experience structural heart products being used. Activities included presenting the concept to leadership for approval, researching existing programs in other business units, setting up a system for structural heart, identifying participants, and helping participants navigate the program.

Direct NVH group within test facility for all vehicle testing. Established new best practice database, providing department with NVH "DNA" readout for each product development gate. Primary development support for acoustic package, BIW structure, and sealing. Ensure vehicle meets voice of customer for quiet car by coordinating Consumers Report simulation ride and drives, objective testing, and educating platform team on designs that will result in a quite car

Coordinated engineers, technicians, and mechanics on all vehicle NVH issues. Lead all windnoise development work including full scale clay model, aero/acoustic buck, and program vehicle testing in the windtunnel.Trained a team of Toluca Mexico plant personnel on how to use sealing root cause tools, resulting in cfm results 27% below the allowable threshold.

Set and verified vehicle functional objectives related to NVH. Provided modal test support, and root cause analysis of axle whine field issue with findings published in SAE paper.

Conducted modal testing for full vehicles, powertrain, and other vehicle components. Collected and analyzed data, wrote detailed test reports, and presented findings to the engineering community.

Developed engineering skills through rotational job assignments in various areas of manufacturing and vehicle engineering while obtaining mechanical engineering masters degree.