Open to new opportunities

Technical Program Manager &
V&V Engineer

7+ years in regulated medical device environments — data collection program ownership, software V&V, and cross-functional program management across firmware, mobile, and cloud platforms. FDA 510(k) submissions, ISO 13485, IEC 62304. Open to TPM, Program Operations, V&V, and Data Program Management roles.

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Quick profile
7+
Years experience
300+
Study participants
7
Products launched
3
510(k) submissions
Program Management Data Collection Ops V&V Engineering Medical Devices IEC 62304 ISO 13485 FDA 510(k) AI Builder
About

Technical Program Manager &
V&V Engineer

Technical Program Manager and V&V Engineer with 7+ years of experience in regulated medical device environments — spanning full product program delivery, large-scale physiological data collection operations, and formal software verification and validation.

At BioIntelliSense, I led iOS/Android mobile applications and the BioHub Wi-Fi gateway from concept through commercial launch while simultaneously owning large-scale data collection programs end-to-end — recruiting 300+ participants, setting up ground truth devices (Faros ECG monitors, Capnostream capnography), authoring protocols, managing ICF and consent workflows, collecting multimodal physiological signals (step/gait, HR, RR, temperature, audio), and owning the full data labeling, annotation, and cleaning pipeline with internal data scientists and Lofty Consulting (Australia).

As V&V Engineer, I led software V&V across firmware, mobile, and cloud platforms — supporting three FDA 510(k) submissions under IEC 62304 and ISO 13485, and authoring 1,000-cycle cleaning and disinfection validation protocols for wearable device reprocessing.

I'm also a hands-on AI builder — built and shipped Fish Smarter using Claude (Anthropic) and Gemini AI APIs, built a MedTech digital twin simulation platform for wearable device V&V, and built this portfolio site with Claude's help. I use Claude daily as a productivity and problem-solving tool.

LocationSan Jose, CA
Emailchensi.xu@yahoo.com
LinkedInlinkedin.com/in/chensixu
FocusTPM · Program Ops · Data Programs · V&V
IndustriesMedTech · Digital Health · AI/ML · Connected Devices
LanguagesEnglish · Mandarin Chinese · Hokkien
SeekingTPM · Program Ops Manager · Data PM · V&V
StatusOpen to work
Experience

Career history

7+ years across program management, physiological data collection operations, and software V&V in regulated medical device environments.

Independent / Self-Employed
Mar 2026 – Present
AI Application Developer
  • Built and shipped Fish Smarter (ca-fish-regs.vercel.app) — a mobile-first PWA integrating Claude (Anthropic) and Gemini AI APIs for real-time fish species identification and California fishing regulation lookup; used Claude throughout the development process as well as at the API integration level
  • Built a MedTech digital twin and simulation platform (wearable-sim.netlify.app) — generates synthetic wearable physiology with circadian coupling, simulates firmware behavior across versions, and stress-tests gateway/cloud pipelines with configurable fault injection; validation engine produces requirement- and risk-mapped traceable pass/fail reports
  • Built personal portfolio website (chensixu.com) with Claude — applying AI tools throughout product design and development workflows
  • Daily Claude user for problem-solving, job preparation, drafting communications, and working through complex decisions
BioIntelliSense, Inc.
Jan 2019 – Mar 2026
Project Manager → V&V Engineer
Project Management (Jan 2019–Sep 2022) · V&V Engineering (Oct 2022–Mar 2026) · Concurrent PM+V&V (Oct 2022–Oct 2023)
  • Led iOS/Android mobile applications and the BioHub Wi-Fi gateway from concept through commercial launch — coordinating engineering, QA, and data collection teams across planning, execution, and deployment into hospital and clinical facility settings; contributed to first FDA 510(k) submission as program coordinator
  • Sole program owner of multiple large-scale physiological data collection programs across 300+ total participants (100–200 external, remainder internal) — personally handling recruitment, ground truth device setup and protocol authoring (Faros ECG monitors, Capnostream capnography), OTA device configuration, ICF and consent documentation, multimodal signal collection (step/gait, HR, RR, temperature, audio/cough detection), and post-collection follow-up
  • Owned data labeling, annotation, and cleaning workflows — collaborating with internal data scientists and Lofty Consulting (Australia) to establish annotation standards and ensure data quality before algorithm handoff; proactively expanded recruitment to diverse external cohorts across age ranges and gender to reduce population bias
  • Led software V&V across firmware, mobile (iOS/Android), and cloud platforms — authoring test strategies, executing protocols, managing Design History Files, and supporting two FDA 510(k) submissions under IEC 62304 and ISO 13485
  • Authored and executed 1,000-cycle cleaning and disinfection validation protocols — evaluating material integrity and essential function retention of wearable devices under real-world decontamination conditions
  • Managed device configuration tracking, CAPA resolution, and audit-ready documentation in Greenlight Guru and Jama Connect throughout the product lifecycle
  • Managed multiple concurrent programs — developing schedules, coordinating up to 18 contributors without direct authority, and implementing JIRA and Confluence workflow improvements that enhanced delivery efficiency
Striiv Inc.
Jun 2015 – Oct 2017
Project Manager
  • Managed delivery of connected consumer wearable hardware and mobile applications — coordinating onshore and offshore engineering and QA teams through planning, execution, and release
  • Notable projects: Striiv Mainline Apps, Pfizer Belive App, CHR1
Skills

Core competencies

Program management, data collection operations, V&V engineering, and AI tools across regulated medical device environments.

Program Management
Cross-functional Program Delivery
Concept-to-Launch Ownership
Agile / Scrum / Hybrid
Risk Management & Mitigation
Stakeholder Communication
JIRA & Confluence (10+ yrs)
Data Collection & V&V
Physiological Data Collection
Data Labeling & Annotation
ICF & Informed Consent Workflows
Ground Truth Device Setup
Medical Device Software V&V
Cleaning & Disinfection Validation
Regulatory & Tools
FDA 21 CFR 820 · IEC 62304 · ISO 13485
ISO 14971 Risk Management
CAPA & Non-conformance Management
Jama Connect · Greenlight Guru
Python (scripting) · SQL
Claude & Gemini AI APIs
Notable Work

Selected projects

Key programs across connected medical devices, data collection, mobile applications, and AI tools.

Data · ML · Program Ops
Physiological Data Collection Programs
Sole program owner of multiple large-scale physiological data collection studies — 300+ participants, multimodal signals (step/gait, HR, RR, temperature, audio/cough), Faros ECG and Capnostream ground truth devices, ICF workflows, and full data labeling and annotation pipeline with Lofty Consulting (Australia).
MedTech · V&V
Connected Medical Device Validation
End-to-end V&V for BioIntelliSense's connected wearable platform — firmware, mobile (iOS/Android), and cloud systems across three FDA 510(k) submissions under IEC 62304 and ISO 13485. Included 1,000-cycle cleaning and disinfection validation protocols.
IoT · Program Management
BioHub Wi-Fi Gateway Program
Led BioHub Wi-Fi gateway from concept through production deployment into hospital and clinical facility settings — hardware platform selection, vendor coordination, HW/SW/FW integration, and cross-functional program delivery.
Mobile · iOS & Android
Mobile Application Programs
Led iOS and Android mobile health applications from concept through App Store launch at BioIntelliSense, and delivered Striiv Mainline Apps, Pfizer Believe App, and CHR1 at Striiv — coordinating onshore and offshore teams through planning, execution, and release.
Quality · Regulatory
FDA 510(k) Design History Documentation
Authored and maintained complete design history files — test protocols, traceability matrices, V&V summary reports, and CAPA records — supporting three FDA 510(k) submissions under IEC 62304 and ISO 13485.
Mobile · Beta Testing
Internal Beta & Dogfooding Programs
Structured beta programs for multiple simultaneous firmware and mobile releases — coordinating test devices, participant feedback, and release readiness across engineering and clinical teams.
Education & Credentials

Academic background

Formal education in informatics and Chinese studies, with professional certifications in project tooling.

Graduate
M.S. Informatics
San Jose State University · 2022–2023
Undergraduate
B.A. Chinese Studies
University of California, Los Angeles · Film Minor · 2011–2013
Associate Degree
A.A. Liberal Arts
De Anza College · Social & Behavioral Science · 2007–2011
🏅
PMP Certification (In Progress)
Project Management Institute · Expected Jun/Jul 2026
🏅
Installing & Administering Atlassian JIRA
Professional Certification · Atlassian
🌐
Trilingual
English · Mandarin Chinese · Hokkien
Personal Projects

Built independently

Side projects built with Claude and Gemini AI — demonstrating hands-on AI application development beyond professional roles.

Fish Smarter icon
LIVE
AI · PWA · Full Stack
Fish Smarter — Own Your Waters.
A mobile-first PWA built with Claude and integrating Claude (Anthropic) and Gemini AI APIs for real-time fish species identification, California fishing regulation lookup, and geospatial MPA boundary mapping with CDFW data. Features 14-day tidal and weather forecasting and offline PWA support.
Claude API Gemini AI Vision Supabase Vercel PWA Geospatial
View Live App →
Wearable Sim icon
LIVE
MedTech · Digital Twin · V&V
Wearable Device Digital Twin & Simulation Platform
End-to-end simulation and validation platform for connected wearable medical devices. Generates synthetic patient physiology (HR, RR, temperature, gait, sleep stages) with realistic circadian coupling, simulates firmware behavior across versions, and stress-tests gateway/cloud pipelines under configurable fault conditions — Wi-Fi outages, BLE failures, packet loss, and auth errors. Validation engine produces traceable pass/fail reports mapped to requirement and risk IDs.
Python Digital Twin BLE Simulation Synthetic Physiology Fault Injection V&V Reporting
View Live App →
Portfolio · Web Development · AI-Assisted
Personal Portfolio Website
Designed and built this portfolio site with Claude's help — deployed on Vercel with a custom domain, Formspree contact form integration, and optimized for recruiter readability. Claude was used throughout the design and development process.
Claude-assisted HTML / CSS / JS Vercel Formspree
You're looking at it →
Testimonials

What colleagues say

Recent LinkedIn recommendations from colleagues at BioIntelliSense.

"I have had the privilege of working with Chensi for over eleven years across two of my companies — first at Striiv, and then at BioIntelliSense. Chensi is one of the most dedicated, thorough, and results-driven professionals I have worked with. At BioIntelliSense, Chensi became the go-to person for complex and high-stakes testing efforts. He executed comprehensive V&V test plans that covered all topologies of data connectivity, from wearable-to-phone Bluetooth pairing, to gateway-to-cloud data pipelines, ensuring end-to-end reliability of our patient monitoring systems. He coordinated across engineering, product, QA, data science, and regulatory teams with ease — including our BioHub Wi-Fi gateway from concept through deployment — with the kind of ownership and accountability that every founder hopes to find in their team."

D
David Wang
CEO & Co-Founder · BioIntelliSense

"Chensi is a conscientious project manager who delivers reliably in complex, fast-moving environments. He led data collection initiatives supporting BioIntelliSense's first FDA 510(k) submission and maintained operational discipline under tight timelines. He also managed the mobile app team, coordinating cross-functional work to support on-time delivery of key releases. Chensi works well amid ambiguity and changing scope by quickly clarifying priorities, surfacing risks early, and turning open questions into practical, actionable plans that keep teams aligned and moving. His hands-on leadership and follow-through were key contributors to the success of the projects he led and the teams' ability to deliver outcomes under pressure."

F
Frank Chan
Technical Project Manager · Microchip (formerly BioIntelliSense)

"Chensi is a detail-oriented and hard working V&V engineer with strong ownership in system testing and firmware validation. He led firmware compatibility testing for our medical devices and gateways, creating structured test protocols and applying a quality-driven CAPA approach to validation and issue resolution. He improved team efficiency through recurring test frameworks and clear documentation, and brought direct hands-on expertise in Android-based systems, debugging and log analysis. Beyond his technical contributions, Chensi is incredibly fun to work with. He is collaborative, positive, and always willing to support the team, even beyond his initial responsibilities. It is his thoughtfulness and genuine kindness that make him someone you can consistently rely on as a team player."

A
Amanda Wong
Technical Product · BioIntelliSense

View full recommendations on LinkedIn →

Contact

Let's connect

Open to TPM, Program Operations Manager, Data Program Management, V&V Engineer, and Quality Engineering roles in medical devices, digital health, and AI/ML environments. Reach out anytime.

📧
Email
chensi.xu@yahoo.com
📍
Location
San Jose, CA
💼
LinkedIn
linkedin.com/in/chensixu
⚡
Response time
Within 24 hours
Sent! I will be in touch within 24 hours.