Fractional 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.