Katelyn Goodwin Email & Phone Number

Redwood City, California, United States

San Francisco Bay Area

San Francisco, California, United States

London, England, United Kingdom

San Francisco, California, United States

San Francisco Bay Area

- Promoted 8/2020 (Same Role/Title)Element Science is a 35-person, Series-C, Class III medical device startup, backed by Google Ventures and Third Rock Ventures. The company is focused on preparing for the clinical trial of a Wearable External Defibrillator. As the associate manager of Manufacturing and Operations, I balanced technical projects with business operations responsibilities and oversaw MTS Procurement.

San Francisco Bay Area

- Contract Manufacturing: worked on outsourcing any non-proprietary assembly work to simplify in-house manufacturing - Sustaining Engineering Projects: Responsible for the packaging and labeling portion of the manufacturing line. Implemented several process development projects using lean manufacturing methodologies to reduce opportunities for human error. https://www.elementscience.com/

Orange County, California Area

(Formerly Abbott Medical Optics, acquired by JNJ in February 2017)Worked on the Advanced Engineering Team to transition new products from the R&D group to international manufacturing sites. This includes designing the manufacturing line and specific work stations to manufacture the new product in a cleanroom environment. A large part of my work was focused on implementing lean six sigma methodologies to analyze line flow (yellow belt certified). This includes creating fixtures via SolidWorks that are used to make assembly processes simple and ergonomic for the operator. On the side, I served as the interim project manager for a process improvement project in Anasco, Puerto Rico. The execution of this project continues to save the site over $70k, annually. Founder and Co-Chair of the JNJ Young Professionals group in Santa Ana. This employee resource group was adopted into the greater JNJ "Millennial Leadership Movement" (MLM) Diversity & Inclusion committee. With this larger MLM family, the committee can now host events with MLM chapters at other JNJ sites. In one year, the committee gained 76 MLM members in Santa Ana. Each month, MLM members hosted at least one event with either a social, philanthropic, or educational purpose.

Lake County, Il

In a 2 year span, I completed four six-month rotations across different divisions of Abbott. In each rotation, I took on operations-related job functions (Quality, Engineering, or Manufacturing). The goal was to gain a diverse skill set that can be applied across the different Abbott businesses. FORTH ROTATION: QA, New Business Integration, Abbott Diagnostics Division (Lake Forest, IL) - Assisted with the new business acquisition of OmniLab (30-person middleware company) by completing a gap analysis between Omnilab's Quality System and the Abbott Quality System- Quality documents were updated accordingly to prepare OmniLab for FDA CDER Certification - Received an Abbott Excellence Award for Pioneering THIRD ROTATION: Abbott Diabetes Care, Operations/Systems Engineering (Witney, England, UK) - Prepared a business case to support the implementation of an Electronic Batch Record System - Assisted with the development of user requirements for an Electronic Batch Record System- Created data flows for the manufacturing processes to convert from paper batch records to electronic batch records using S88/S95 framework & ensuring that Part 11 Data Integrity Standards are fulfilled - Facilitated meetings with vendors and consultants to select an MES vendor and develop a cost model for the system implementation SECOND ROTATION: Abbott Diabetes Care, Global Sourcing/Third Party Manufacturing (Alameda, CA)- Reviewed the BOMs for 7 glucose monitors to look for cost savings through component price negotiations, design changes, or component replacement. FIRST ROTATION: Abbott Vascular, R&D Product Development (Temecula, CA)- Completed a Proof of Concept report for next-generation catheter design, used JMP for the statistical analyses - Helped devise a novel in-vitro testing method to evaluate catheter tip designs by emulating the tortuous path a catheter navigates from the femoral artery to the heart

San Luis Obispo, Ca

Worked as a liaison between Cal Poly, San Luis Obispo students and Abbott's Human Resource Team to inform students of job opportunities with Abbott.

Lake County, Il

Abbott Nutrition – Regulatory Affairs - Compiled database of international regulatory registration requirements using Visual Basic- Abbott Regulatory Affairs Global Conference Participant

Lake Forest, Il

Abbott Diagnostics – Global Quality Assurance Project Management- Completed Lean Six Sigma & DMIAC training & Kaizen leadership workshop- Created a statistical summary of engineering lab results – earned Bronze Award - Organized and updated team SharePoint sites- Assisted in the organization of Clinical Data Reporting and Analysis using Cloud Technology - Created statistical reports to help prepare ADD facilities for CEBR approval

Alameda, Ca

Abbott Diabetes Care – Regulatory Affairs - Established a sorting system in SharePoint to process change requests- Created a database of international medical device registration requirements- Participated in International Summit Conference with affiliates in Asia-Pacific