Comprehensive consulting for medical device manufacturing
Manufacturing Engineering
Hiring and developing manufacturing engineering talent, organizational strategy, process optimization, and continuous improvement programs.
Quality & Regulatory
ISO 13485, MDSAP compliance, 510(k) submissions, EU MDR technical files, design controls, and risk management.
Process Excellence
Scientific molding, DOE studies, process validation (IQ/OQ/PQ), automation, and process troubleshooting.
Equipment Maintenance
Preventive maintenance programs, mold maintenance, equipment lifecycle management, and CMMS implementation.
Facility Design
Greenfield site design, cleanroom development (ISO 7/8), utility systems, and layout optimization.
Supplier Development
Global supplier strategy, qualification programs, audits, and supply chain optimization.
Strategic Advisory
Technology transfer, due diligence, M&A support, expert witness services, and custom training programs.
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January 2026
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Time zone: America/Los_Angeles
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