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Delivering measurable results across medical device development, regulatory compliance, engineering analysis, and digital transformation. Each service backed by 10+ years of proven success.

Expertise & Focus Areas

Wall of ideas

Medical Device
Program Management

Leading complex Class II/III device programs from concept through FDA/EU approval and commercial launch.
 

  • What I Deliver:

    • PMO Establishment & Leadership: Built Project Management Offices for LVAD (Class III), IV infusion systems (Class II), and orthopedic platforms coordinating 40+ cross-functional team members

    • Regulatory Success: Led Class III LVAD to FDA IDE approval (Q1 2024), managed EU MDR compliance for 25+ IV set product families, delivered 510(k) submissions for orthopedic and cardiovascular devices

    • Schedule & Budget Control: Managed multi-million dollar programs using MS Project, Power BI dashboards, and KPI tracking—delivered on time, within budget, with <3% variance

    • Cross-Functional Leadership: Coordinated R&D, Clinical, Regulatory, Quality, Manufacturing, and Operations teams across multiple global sites
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  • Tools & Methodologies:

    • MS Project | Power BI | Jira | Agile/Waterfall Hybrid | QCBD | Greenlight Guru | SAP | WBS Development | Critical Path Analysis | Risk Management
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  • Proven Results:

    • ✅ FDA approval for Class III LVAD
      ✅ 35% efficiency improvement through standardized workflows
      ✅ $2M+ program budgets managed successfully
      ✅ 2x Employee of the Year (2021, 2022)

Mechanical Design &
FEA Engineering

Creating biomechanically optimized medical devices through advanced CAD modeling and computational analysis.
 

  • What I Deliver:

    • Orthopedic Implant Design: Designed 50+ custom knee/hip implants, total knee systems, wrist fracture plates, and elbow prostheses integrated into commercial platforms (Enovis Physica, Acumed Acu-Loc)

    • Finite Element Analysis: Performed advanced FEA using Abaqus, ANSYS, and FE-SAFE—saved $150K+ by eliminating physical prototypes, reduced stress concentrations 35%, accelerated validation 40% via GPU computing

    • Design Validation: Led cadaver lab studies, ASTM testing protocols, surgeon collaboration, and verification/validation programs achieving 96% successful surgical outcomes

    • Manufacturing Optimization: Created 200+ GD&T drawings, DFM collaboration reducing costs 18-35%, patent development (2 issued U.S. patents)
       

  • Technical Skills:

    • CAD (Creo, SolidWorks) | FEA (Abaqus, ANSYS, FE-SAFE) | GD&T per ASME Y14.5 | Rapid Prototyping | 3D Scanning & Reverse Engineering | CUDA Programming | Python/MATLAB Automation
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  • Proven Results:

    • ✅ $150K cost savings through FEA vs. physical testing
      ✅ 50+ patient-specific custom implants delivered
      ✅ 2 issued U.S. patents for surgical instruments
      ✅ 3 peer-reviewed publications in orthopedic journals

Engineering Component Blueprint
Piles of Paper

Quality & Regulatory Compliance (QMS)

  • FDA 21 CFR 820 | ISO 13485 | ISO 14971 | EU MDR 2017/745 | ASTM Standards | Design History Files | Verification & Validation | Clinical Trials (IDE) | Notified Body Interactions
     

  • ​Proven Results:

    • ✅ 100% regulatory submission success rate
      ✅ Zero major FDA observations during audits
      ✅ 35% reduction in design change cycle time
      ✅ Six Sigma Black Belt certified (ASQ)

Biomechanics Research & Clinical Collaboration

Translating clinical needs into evidence-based device designs through rigorous research.
 

  • What I Deliver:

    • Hospital for Special Surgery Collaboration: Conducted multi-institutional research with renowned orthopedic surgeons (Drs. Wright, Padgett, Sculco) characterizing TKA constraint mechanisms

    • Clinical Validation: Led 15+ cadaver laboratory sessions, surgeon usability studies (4.6-4.8/5.0 ratings), and post-market clinical follow-up

    • Academic Dissemination: Published 3 peer-reviewed journal articles, presented at ISTA and ORS conferences, disclosed IP royalty relationships with Lima Corporate and Exactech

    • Outcomes Research: Correlated design parameters with clinical success rates (95.8% survivorship), patient satisfaction (KSS 88±12), and complication rates
       

  • Research Capabilities:

    • Clinical Study Design | Cadaver Lab Testing | ASTM Testing Protocols | Statistical Analysis | Technical Writing | Conference Presentations | IP Strategy
       

  • Proven Results:

    • ✅ 3 peer-reviewed publications
      ✅ 5 national/international conference presentations
      ✅ IP royalty relationships established
      ✅ 95.8% implant survivorship at 5-year follow-up

Doctor Writing Notes
Website setup on laptop

Digital Strategy &
Web Development

Building high-converting websites and SEO strategies that drive measurable business growth.
 

  • What I Deliver:

    • Custom Website Development: Created professional sites for healthcare (Woodbridge Pharmacy) and hospitality (LA Condotel) clients from requirements through launch

    • Local SEO Mastery: Achieved Page 1 Google rankings for 18-22 target keywords, 4.6-4.8 star ratings with 45-78+ reviews, 40-80% increases in customer inquiries

    • Conversion Optimization: Designed phone-first reservation workflows, mobile-responsive layouts (68-72% mobile traffic), HIPAA-compliant forms, and bilingual content (Korean/English)

    • Performance & Analytics: Implemented GA4 tracking, Google Search Console monitoring, <3 second load times, and monthly performance reporting

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  • Technical Stack:

    • HTML/CSS/JavaScript | WordPress | Responsive Design | Google Analytics 4 | Google Search Console | Schema Markup | On-Page SEO | Google Business Profile | Bilingual Content | WCAG Accessibility
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  • Proven Results:

    • ✅ 80% increase in phone inquiries (LA Condotel)
      ✅ 40% increase in patient traffic (Woodbridge Pharmacy)
      ✅ 380-450% organic search traffic growth
      ✅ $45K+ annual savings from reduced OTA commissions      ​​​

AI-Enhanced Content & Automation

Leveraging AI tools and automation to accelerate technical documentation and data insights.
 

  • AI-Enhanced Content & Automation

    • Leveraging AI tools and automation to accelerate technical documentation and data insights.

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  • ​What I Deliver:

    • AI-Powered Technical Writing: Utilizing Large Language Models (LLMs) to accelerate creation of case studies, white papers, compliance summaries, and regulatory documentation while ensuring accuracy

    • Data Dashboards: Building custom Power BI and Tableau dashboards tracking KPIs, project milestones, budget variance, and operational efficiency

    • Process Automation: Developing Python/MATLAB scripts automating repetitive engineering calculations, data analysis, and report generation

    • Digital Transformation: Implementing secure forms, automated data feeds, and efficient workflows for medical device startups

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  • Tools & Technologies:

    • Python | MATLAB | Power BI | Tableau | Large Language Models | API Integration | Data Visualization | Workflow Automation

Artificial Intelligence Circuit
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