Biomedical Engineering Leader with 15+ years of experience driving full lifecycle development, scale-up, and sustaining of Class II and Class III medical devices across implantables, active devices, and diagnostics. Proven track record of applying systems engineering, process development, and manufacturing science to optimize complex regulated environments.

Core Technical Competencies: Product Development & DFM: Expert in early-phase design through commercialization, with specialization in Design for Manufacturability (DFM/DFx), Design for Reliability (DfR), and risk-based design controls (ISO 14971). Delivered Class III implants with FDA and global regulatory approvals ahead of schedule and under budget.

Process Engineering: Advanced process characterization, DOE, process validation (IQ/OQ/PQ), and tech transfer for Class II/III devices including confidential implants, artificial valves, and glucose sensors. Achieved 25% yield gains, 50% labor cost reduction, and 75% COGS improvements via lean design integration and automation.

Sustaining Engineering: Led multi-site sustaining teams for legacy product support, cost-downs, supplier validation, and process remediation. Utilized DMAIC and A3 methodologies to eliminate 100% overdue service requests, reduce downtime by 75%, and save 5,000+ labor hours annually.

Manufacturing Science & Ops: Oversaw high-volume CGMP manufacturing (700+ FTEs), scaling implantable sensor production 10X. Implemented ISO 13485-compliant QMS processes and MES systems, maintaining zero audit findings and improving equipment uptime to 100% across functions.

Automation & Data Systems: Drove process automation through digital transformation and MES/SCADA integration. Applied SPC, FMEA, root cause analysis (5 Whys, fishbone), and advanced statistical methods for predictive performance monitoring and equipment qualification.

Cross-Functional Program Leadership: Managed global tech transfers, NPI, and site-to-site production movement with full accountability across engineering, quality, regulatory, and supply chain. Removed 83% of low-value sustaining work via ROI-driven project reprioritization aligned with quality and production KPIs.

Regulatory & Compliance: Deep familiarity with FDA 21 CFR Part 820, ISO 13485, MDSAP, and CE Marking requirements. Successfully led global audits, remediation efforts, and Class III submission programs in collaboration with RA/QA.

Candidate seeks a formative role in California, Ireland, Australia, New Zealand.