Dynamic Biomedical Engineer with a decade of experience in designing and analyzing innovative solutions for complex challenges in medicine and biology. Recognized for exceptional critical thinking and communication skills, along with a proven ability to adjust, install, and evaluate biomedical equipment for optimal safety and efficiency. A solution-oriented professional certified in Agile Scrum and Medical Device Regulation, committed to advancing healthcare technology through effective collaboration and strategic problem-solving.
Hi, I’m
Argus Sun
Summary
Overview
11
years of professional experience
1
Certification
Work History
California Department of Public Health – Food and Drug Branch
Research Scientist III – Medical Devices, Biologics
01.2021 - 01.2025
Job overview
- Led system-level risk analyses and safety assessments for Class II/III medical devices across multiple therapeutic areas
- Developed and maintained design history files and risk management files supporting regulatory compliance (ISO 14971, 21 CFR 820)
- Conducted quality compliance inspections and audits for medical device manufacturers under 21 CFR 820
- Managed medical device recall processes, interfacing with Quality and Field Action Teams at device manufacturers
- Systems Engineering & Risk Management:
- Regulatory & Technical Leadership:
- Subject Matter Expert for complex device and biologic regulatory issues, providing technical guidance across cross-functional teams
- Supported FDA data-sharing initiatives and regulatory submissions (21 CFR 807)
- Developed and delivered training programs on Software as Medical Device (SaMD) standards (IEC 62304 & 82304)
- Led development of iOS Medical Device Manufacturer Inspection application using AI-based object detection (YOLOv6)
- Requirements Management & Documentation:
- Implemented version control systems for regulatory software tools and OpenFDA REST API integration
- Managed traceability requirements using UDI systems (21 CFR 801) for device identification and tracking
- Processed and analyzed Medical Device Reporting (MDR) adverse events under 21 CFR 803
- Supported licensing and establishment registration for biologics manufacturing facilities
BioPoets/Lawrence Berkeley National Laboratory
Biomedical Engineer/Postdoctoral Fellow
01.2015
Job overview
- Applied systems engineering principles to plasmonic biosensor development and electric field modeling
- Generated design specifications, design inputs, design outputs, and design verification protocols for oxygen sensor systems
- Executed design verification activities ensuring product safety and performance requirements
- Design Controls & Verification:
Eidolon Hydros Inc
Senior Biomedical Engineer/Co-Founder
01.2018 - 01.2021
Job overview
- Led systems engineering approach for hydrogel-coated titanium implant development from concept through design verification
- Developed Design Master File (DMF) documentation for novel combination product regulatory pathway
- Executed Installation Qualification (IQ) and Operational Qualification (OQ) protocols for cleanroom packaging facility (21 CFR 820)
- Participated in IEEE Device Standards Committee, contributing to industry standards development
- System Architecture & Product Development:
- Cross-Functional Integration & Leadership:
- Managed interdisciplinary cross-functional teams across mechanical, biological, and manufacturing engineering disciplines
- Integrated real-world evidence (RWE) digital health data collection using wearable device platforms
- Conducted Qualified Person (QP) audits for packaging cleanroom compliance and quality systems
- Published peer-reviewed research on medical device innovation and COVID-19 diagnostic technologies
Neurosim (UCLA/Blackstone Launchpad)
Engineering Co-Founder
01.2014 - 01.2018
Job overview
- Led cross-platform mobile application development for stroke education medical device software
- Managed product lifecycle from concept through commercialization in regulated healthcare environment
- Product Development Leadership:
Sanford Regenerative Medicine Consortium
Postdoctoral Fellow
01.2016 - 01.2017
Job overview
- Designed and developed microfluidic cell culture systems for advanced therapy medicinal products (CAR-T cells)
- Created comprehensive CAD models and design specifications for complex biological systems
- Contributed to workflow software development for NGS sequencing data processing and analysis
- Collaborated with interdisciplinary teams on 3D culture system verification and validation protocols
- System Design & Verification:
Education
UCLA School of Engineering
PhD from Biomedical Engineering
University Overview
UCLA Extension
Certificate from Biotechnology and Medical Device Engineering
University Overview
Concentration: Combination Products
Caltech Center for Technology Management Education
Certificate from DevOps
University Overview
University of Manchester
Certificate from Bioprocess & Industrial Biotech
University Overview
Skills
- Standards & Regulations: 21 CFR 820, ISO 13485, ISO 14971, IEC 60601, IEC 62304, IEC 82304
- Systems Engineering Tools: Requirements management, design controls, risk analysis, V&V protocols
- Programming & Development: Python, iOS development, AI/ML integration, database management
- Languages: English (Native), Chinese, Spanish, French
Accomplishments
Accomplishments
- Successfully supported multiple Class II/III medical device regulatory submissions and approvals
- Led cross-functional teams ranging from 5-15 engineers across mechanical, electrical, and software disciplines
- Published 3+ peer-reviewed publications in medical device innovation and regulatory science
- Developed and implemented quality management systems achieving 100% compliance in regulatory audits
- Mentored junior engineers and interns on medical device development and regulatory compliance
Affiliations
Affiliations
- Regulatory Affairs Professional Society (RAPS)
- International Society of Pharmaceutical Engineers
- Institute of Electrical and Electronic Engineers (IEEE)
- Food and Drug Law Institute
- American Chemical Society
- American Society of Cell Biology
Certification
CSM - Certified Scrum Master
RAC-Devices - Regulatory Affairs Professional
Languages
Spanish
Professional Working
Chinese (Mandarin)
Native or Bilingual
Chinese (Cantonese)
Limited Working
Core Competencies
Core Competencies
- Systems Engineering & Architecture: System-level design, requirements management, cross-functional integration, verification & validation
- Regulatory Compliance: 21 CFR 820, ISO 13485, ISO 14971, IEC 62304, IEC 62304, 21 CFR 803/807, FDA 510(k) processes
- Risk Management: FMEA, system-level risk analysis, medical device safety programs, quality compliance audits
- Medical Device Development: Class II/III device development, design controls, design history files, combination products
- Technical Leadership: Cross-functional team coordination, technical documentation, regulatory submissions support
Timeline
Research Scientist III – Medical Devices, Biologics
California Department of Public Health – Food and Drug Branch
01.2021 - 01.2025
Senior Biomedical Engineer/Co-Founder
Eidolon Hydros Inc
01.2018 - 01.2021
Postdoctoral Fellow
Sanford Regenerative Medicine Consortium
01.2016 - 01.2017
Biomedical Engineer/Postdoctoral Fellow
BioPoets/Lawrence Berkeley National Laboratory
01.2015
Engineering Co-Founder
Neurosim (UCLA/Blackstone Launchpad)
01.2014 - 01.2018
UCLA Extension
Certificate from Biotechnology and Medical Device Engineering
Caltech Center for Technology Management Education
Certificate from DevOps
University of Manchester
Certificate from Bioprocess & Industrial Biotech
UCLA School of Engineering
PhD from Biomedical Engineering
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