Hannah J. Suniga
San Diego,CA
Summary
I am a biomedical engineer with experience in managing the design control process from start to finish in a fast paced startup medical device company. I have deep experience working closely with various departments including Quality, Regulatory, Marketing, Sales, Clinical, and Manufacturing. I have implemented everything from small design changes to full design control projects ending with successful 510k submission. I excel at communication and organization as well as having a knack for big-picture critical thinking.
Overview
8
8
years of professional experience
Work History
R&D Consultant
Potrero Medical
04.2023 - Current
- Co-Authored FDA Pre-sub document with Regulatory and Quality team members
- Assisting the R&D team with finalizing V&V activities for a software update
- Managing the requirements development for the next extensive software update
R&D Project Manager/Product Development Engineer
Potrero Medical Inc
09.2017 - 03.2023
- Led the design and development of a novel floor stand and mount for the Accuryn Monitor, resulting in a patent-pending design
- Managed the Design Control process from concept to commercial release for the SmartFoley Adapter, enabling universal foley connectivity with the Accuryn Monitor
- Coordinated the release of two new IAP foley sizes, authoring the 510(k) submission and achieving 510(k) clearance
- Successfully managed the design change process for the AccuTab project (PPE reduction on Covid-19 patients) and
- Managed several extensive Software Updates to the Accuryn and AccuTab devices
- Provided field support, conducted user interviews, and managed budget projections for the R&D department
- Implemented Sprint/Scrum methodology in the R&D department as the Scrum Master
- Led company-wide Jama integration.
Engineering Intern
Potrero Medical, Inc
06.2017 - 09.2017
- Worked in various departments of a startup medical device company, including Research & Development, Quality, Regulatory, Manufacturing, Sales, and Clinical
- Created dozens of SolidWorks designs, generated technical drawings, and developed streamlined manufacturing instructions for the Floor Stand Assembly
- Conducted design brainstorming, analysis, and decision-making for the final design
- Developed and executed testing procedures and standard testing methods for Verification & Validation (V&V) testing of Gen1.65 and Gen2.0 System and Subsystem
- Contributed to the development, research, testing, and documentation of new designs and parts for the Accuryn Assembly
- Gained experience in Quality, GDP, and DCO Process.
Engineering Intern
Tandem Diabetes Care Inc.
06.2015 - 12.2015
- Leading a multi-disciplinary intern team to produce a preliminary software prototype within 2 months
- Designed over ten iterations of a part for a next-generation insulin pump using SolidWorks
- Mastered the use of the Objet 3D printer and produced various parts with different materials
- Analyzed push force for assembly using Instron testing equipment
- Constructed Quality documents, including BOM, DHR, DMR, Process Assembly Flow, and Work Instructions.
Scientific Intern
Stanford University
01.2016 - 06.2016
- Worked in Irving Weissman's Stem Cell Biology and Regenerative Medicine Laboratory on factors that regulate cancer recognition by the immune system
- Imaging with Confocal Microscope
- Flow Cytometry
- Phagocytosis Assays
Education
Masters of Science - Biomedical Science, Biotechnology
San Francisco State University
San Francisco, CA2018
Bachelor of Science - Biomedical Engineering
California Polytechnic State University, San Luis Obispo
San Luis Obispo, CA06.2016
Associate of Science - Biology
San Diego Mesa Community College
San Diego, CA05.2014
Skills
- SolidWorks
- 3D Printing
- Machine Shop
- Minitab
- Microsoft
- Technical Writing
- Jama
- Jira
- Arena
- Smartsheet
- Project Management
Patents
- Accuryn Floor Stand
- Accuryn Mount
- Accuryn High Mount
- Accuryn Foley Catheter Tray
Timeline
R&D Consultant
Potrero Medical
04.2023 - Current
R&D Project Manager/Product Development Engineer
Potrero Medical Inc
09.2017 - 03.2023
Engineering Intern
Potrero Medical, Inc
06.2017 - 09.2017
Scientific Intern
Stanford University
01.2016 - 06.2016
Engineering Intern
Tandem Diabetes Care Inc.
06.2015 - 12.2015
Masters of Science - Biomedical Science, Biotechnology
San Francisco State University
Bachelor of Science - Biomedical Engineering
California Polytechnic State University, San Luis Obispo
Associate of Science - Biology
San Diego Mesa Community College
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