Rodrigo Umanzor
Product Design Engineer
Seattle,WA
Summary
Product Engineer with 2+ years of professional industry experience and a technical background in design and development of medical devices per design controls of FDA/Regulatory Affairs, 510(k), ISO 13485, ISO 14971. Experience in developing project specific design requirements and conducting risk analysis, design verification, and validation activities.
Overview
5
5
years of post-secondary education
7
7
years of professional experience
Work History
Product Design Engineer
Concure Oncology, Inc
Mercer Island, WA
05.2019 - 07.2021
- Designed and developed 3D printed template grid for breast brachytherapy
- Collaborated with manufacturer to optimize the Carbon Digital Light Synthesis and manufacturing process
- Engaged with clinicians and key opinion leaders to obtain preliminary clinical feedback on prototype design and functional performance
- Tested completed projects for functionality and implemented changes to production methods to rectify issues in final design
- Documented and updated build, quality, and performance records
- Validated packaging and sterile barrier systems per ASTM D4169 and ISO 11607-1 standards
- Coordinated and advised ethylene oxide batch sterilization process with a contract sterilization facility
Inertial Orthopedics Biomedical Engineer
University of Washington
Seattle, WA
09.2018 - 06.2019
- Designed and manufactured a wearable assistive tool for physical and occupational therapists intended to optimize workflow and improve patient compliance
- Formulated a detailed business plan with information collected through interviewing and collaborating with private and non-private practicing physiotherapists in the Seattle area
- Placed into the final round of the Holloman Health Innovation Challenge at UW
Polymer Design Researcher
Polymer Engineering Center, PEC
Madison, WI
10.2017 - 05.2018
- Acted as primary researcher in charge of designing an interactive human shoulder model to be used for instruction purposes.
- Processed patient CT scans using Materialise Mimics medical imaging software to isolate a 3D model of the glenohumeral and sternoclavicular joints compatible for 3D printing.
- Integrated 3D printing techniques with PDMS constructs to fabricate and assemble a synthetic musculoskeletal model capable of the dynamic movements about the shoulder joint.
- Awarded 1st place for student poster presentation at the 18th Annual PEC International Colloquium.
Biomedical Design Team Member
University of Wisconsin
Madison, WI
09.2015 - 05.2018
- Designed a novel delivery system to reduce compressive loading in osteochondral allograft transplant procedures.
- Demonstrated a 12% increase in chondrocyte viability with proposed delivery method using fresh bovine cartilage specimens and confocal microscopy quantification.
- Synthetic Bone Implant.
- Created a bioreactor and thermistor circuit to mimic in vivo body temperature and pH conditions.
- Fabricated a synthetic bone graft prototype for bone fusion in an adult human calcaneus.
- Developed MTS compression testing protocols for bone graft samples and assessed the data with shear-stress diagrams constructed using MatLab code.
- Expandable Bone Graft Support System.
- Devised an expandable bone graft support system for intervertebral fusion surgery capable of withstanding up to a 500 N load and compatible with delivery through a 5mm catheter.
- Simulated compressive forces and data analysis of support system behavior using finite element analysis on SOLIDWORKS.
Tissue Engineering Lab Member
University of Wisconsin
Madison, WI
09.2016 - 01.2017
- Cultured a cell line of MC3T3-E1 (subclone 4) to study in vitro osteoblast differentiation and encapsulated cells in a 3-dimensional alginate matrix and assessed viability using live/dead stains with fluorescent microscopy.
- Developed a Click-iT EdU protocol to quantify newly synthesized DNA to assess the effects of seeding density on cell proliferation.
Education
Master’s - Applied Bioengineering
University of Washington
Seattle, WA 09.2018 - 06.2019
Bachelor of Science - Biomedical Engineering
University of Wisconsin - Madison
Madison, WI 09.2013 - 05.2018
Skills
Design for Manufacturability
CAD (Solidworks)
Manufacturing Processes
Medical Device Regulatory Affairs
Medical Device Packaging and Sterilization
DFMEA
Timeline
Product Design Engineer
Concure Oncology, Inc
05.2019 - 07.2021
Master’s - Applied Bioengineering
University of Washington
09.2018 - 06.2019
Inertial Orthopedics Biomedical Engineer
University of Washington
09.2018 - 06.2019
Polymer Design Researcher
Polymer Engineering Center, PEC
10.2017 - 05.2018
Tissue Engineering Lab Member
University of Wisconsin
09.2016 - 01.2017
Biomedical Design Team Member
University of Wisconsin
09.2015 - 05.2018
Bachelor of Science - Biomedical Engineering
University of Wisconsin - Madison
09.2013 - 05.2018