Summary
Overview
Work History
Education
Skills
Patents
Timeline
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John DePalo

San Francisco,CA

Summary

Highly motivated biomedical engineer with prowess in medical device engineering, research & development, and product design. Proven track record of driving innovation, spearheading projects, and delivering exceptional results. Seeking to leverage my experiences to lead research and development of medical devices.

Overview

4
4
years of professional experience

Work History

Device Engineer I

Genentech, Inc.
02.2022 - Current
  • Implemented the design control process (ISO 13485, FDA 21 CFR 820, test method development) for drug-device combination products (ex. ocular implant, specialty needle, pre-filled syringe) to enable use in clinical trials and commercially.
  • Drove success in cross-functional workstreams through interfacing with external partners as well as internal process and manufacturing, clinical, quality, and regulatory stakeholders.
  • Optimized auxiliary needle for ocular implant by developing (using SolidWorks) and manufacturing (using SLA and FDM 3D printing) novel configuration that improved device performance by 50%.
  • Worked closely with external suppliers to develop ophthalmic pre-filled syringe intended to be used with all upcoming drug products therefore significantly reducing time to market.
  • Developed and authored test methods, protocols, and reports to evaluate previously uncharacterized device attributes, demonstrate safety during misuse cases, and ensure that potential product improvements are rigorously and thoroughly evaluated.

Associate Engineer

Genentech, Inc.
07.2021 - 02.2022
  • Developed test methods and custom fixtures to support the development and selection of device designs and components for various projects.
  • Executed Design Verification testing to support regulatory filings.
  • Consulted as the lead verification engineer in areas of testing strategy, test methods, test requests, and testing operations for ophthalmologic pre-filled syringe project.
  • Processed and evaluated clinical and commercial complaints for ocular implant.
  • Applied GMP and GDP procedures to ensure data integrity and maintain compliance.

Student Engineer

Encellin
09.2020 - 06.2021
  • Partnered with Bay Area startup to develop an insertion tool for a subcutaneous implant used to treat type 1 diabetes.
  • Collaborated with key stakeholders to develop comprehensive design control documentation.
  • Designed (Solidworks) and manufactured (SLA & FDM 3D printing) various prototypes and developed test protocols to evaluate feasibility and device usability.
  • Optimized final design based on test results and delivered a successful implant delivery system to partner company.

Education

Bachelor of Science - Bioengineering, Concentration in Medical Devices

Santa Clara University
Santa Clara, CA
06.2021

Skills

  • CAD (SolidWorks)
  • Rapid Prototyping
  • FAD/ISO Standards
  • Design Controls & Electronic Design Control Software
  • Design for Manufacture
  • Technical Writing
  • Statistical Software (Minitab)
  • CT & OCT Scanning
  • 3D-Printing (SLA and FDM)

Patents

  • Fermanian S., Horvath J., Ohri P., DePalo J., Valadez G. 2023. Lubricated Fluid Exchange Needle for Enhanced Performance of Refillable Implantable Ocular Drug Delivery System. Application No. 63/516456, Filed 28 July 2023.

Timeline

Device Engineer I

Genentech, Inc.
02.2022 - Current

Associate Engineer

Genentech, Inc.
07.2021 - 02.2022

Student Engineer

Encellin
09.2020 - 06.2021

Bachelor of Science - Bioengineering, Concentration in Medical Devices

Santa Clara University

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John DePalo