Humiint

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Hello, I'm Vincent Operations.

Details

  • Professional CategoryConsulting & Advisory
  • Location
  • Years of Relevant Experience20+ years
  • Seniority LevelC-Suite
  • Consulting Rate (Hourly)200

Headline

Fractional COO - Medical Device Operations

Experience

Fractional COO

ONYMay 2025 - CurrentFractional COO - Medical Device Operations ONY · Full-timeONY · Full-time Jun 2024 - Present · 1 yr 5 mosJun 2024 to Present · 1 yr 5 mos Singapore · HybridSingapore · Hybrid Self-Employed | Jun 2024 - Present | Singapore/France I help medical device startups build, scale, and certify operations from prototype to profitable production. 🔹 **Operations & Manufacturing** — Manufacturing setup and industrialization strategy — Production scale-up and process optimization — Lean Six Sigma cost reduction (20-30% savings achieved) — Supply chain establishment and vendor qualification — Site selection and equipment validation 🔹 **Quality & Regulatory Systems** — ISO 13485 QMS implementation and certification (100% success rate) — Regulatory strategy: FDA 510(k), CE Mark (MDR/IVDR), NMPA — Quality Management Representative (QMR) services — Audit preparation and execution (FDA, MDSAP, Notified Bodies) — Risk management (ISO 14971) and design controls 🔹 **Operational Excellence & P&L** — Fractional COO engagements for funded startups — Cost reduction programs and OEE improvements — DMAIC problem-solving and root cause analysis — Operational KPIs and performance management — Budget optimization and P&L support 🔹 **Strategic Leadership** — Go-to-market and commercialization strategy — Fundraising support and investor relations — Team building and capability development — International expansion (US, EU, China markets) — Custom digital solutions (Python, AI/ML automation for operations) **Client Profile:** Seed to Series B medical device startups needing experienced operational leadership to scale efficiently and achieve regulatory approvals. **Availability:** On-site, hybrid, and remote engagements across Europe, Asia, and USA.

Industry

  • Hospitals and Health Care
  • Manufacturing
  • Technology, Information and Media
  • Transportation, Logistics, Supply Chain and Storage

Specific Jurisdictions That I'm Qualified In or Can Cover

France
Singapore

Language(s)

  • English
  • French

Education

ESIEE

MastersEngineering -

MBA (Paris Dauphine PSL 2027)

MastersBusiness - Current

I am interested in

  • Career Opportunities
  • Building my online Brand / Presence