Professional Summary An Engineering and Management Professional with extensive experience in Product Development and Engineering Consulting. Managerial Competencies * Service Delivery * Project management * Customer management * Onboarding new team * Performance management Technical Competencies Medical Devices/Life Sciences * Design remediation of medical devices * Remediation of Knee implant parts * Reverse engineering * Post-merger integration activities * DFMEAs and PFMEAs and 21 CFR * Interface Design in ANSI/AAMI HE75 and ISO/IEC 62366 environment * Design controls for FDA Class 1, 2 devices * Process validation * Medical device labeling * Complaint remediation * Tooling development * DHF Documentation * Manufacturing transfers Engineering * New product development and Engineering change management in a regulated environment Production / Manufacturing

Highlights:

• Consulting
• Medical Devices
• Engineering Design
• Engineering
• Product Development
• Documentation
• Ansi (Am Natl Stds Inst)
• FDA