Ryan Morgan
San Diego
Summary
Engineering leader who turns complex diagnostic systems into market-ready products through integrating workflows, solving regulatory challenges, and cutting assay runtimes by 67% to enable commercial success. Known for bridging assay, hardware, and software teams to deliver reliable, compliant, and scalable solutions in high-stakes environments. Patent holder with proven success in regulatory response, manufacturability improvements, and cross-functional leadership.
Overview
9
9
years of professional experience
1
1
Certification
Work History
Manager, Systems Integration Engineering
Truvian Health
San Diego
07.2018 - Current
- Owned full system workflow integration from early prototypes through clinical units, progressing from absorbance module authority to architecting cross-modality workflows.
- Reduced assay runtime by 67% through workflow redesign, non-critical step elimination, and coordination between assay, software, and leadership teams.
- Integrated absorbance module to achieve substantial equivalence to predicate devices, authoring requirements, verification/validation protocols, and manufacturing qualification standards.
- Sole owner of several FDA deficiency responses related to risk analyses and implementing mitigations that lowered system risk scores.
- Developed automated data analysis and outlier detection tools in Python, improving investigation speed and decision-making.
- Led root cause investigations for system anomalies, driving design and manufacturing changes that improved reliability.
- Named inventor on system-wide patent for multi-analyte detection
- Manage a team of engineers, setting OKRs, conducting reviews, and supporting career development.
Laboratory Consultant
Dare Bioscience
San Diego
01.2018 - 05.2018
- Launched first in-house laboratory aimed at strengthening acquisition due diligence efforts.
Formulated and validated drug release protocols to ensure alignment with commercialization strategies.
Post-Market Surveillance Analyst
Abbott
Sunnyvale
10.2016 - 01.2018
- Performed comprehensive failure mode analyses and risk assessments to ensure FDA compliance.
Partnered with engineering teams to utilize post-market surveillance data for iterative design improvements.
Education
Masters of Engineering - Bioengineering
University of California, San Diego
La Jolla, CA06-2018
Bachelor of Science - Biomedical Engineering
University of California, Davis
Davis, CA06-2016
Skills
- Medical Device Systems Integration (Optical, Mechanical, Assay)
- Cross-Functional Leadership
- FDA Verification & Validation (ISO 13485)
- Design Controls & Risk Management (ISO 14971)
- Root Cause & Failure Mode Analysis
- Automated Data Processing & Visualization (Python)
Certification
- Tech Management & Entrepreneurial Certification — UC San Diego, 2018
- Micro-MBA — UC San Diego, 2019
Timeline
Manager, Systems Integration Engineering
Truvian Health
07.2018 - Current
Laboratory Consultant
Dare Bioscience
01.2018 - 05.2018
Post-Market Surveillance Analyst
Abbott
10.2016 - 01.2018
Masters of Engineering - Bioengineering
University of California, San Diego
Bachelor of Science - Biomedical Engineering
University of California, Davis
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