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