Medical Device Compliance Quality Risk Management@Operation Rehabilitation
Verified
An accomplished, results-oriented Principal Engineer/Chief Technology Officer (CTO) and Six Sigma Blackbelt with a
manufacturing, process, and project engineering background to include vast experience and passion for medical device/
pharmaceu9cal/biotechnology Design for Manufacturing (DFM), valida9on, risk management, and design. Demonstrated
ability in vision development, strategic planning, change management, team building, cost control, profit op9miza9on,
and design control. Countless numbers of successful mul9-million dollar interna9onal projects in the Medical Device,
Pharmaceu9cal, and Biotechnology Industries. Responsible for internal audits and developing technical remedia9on
plans, resource plans, and robust schedules that remediated Class II and Class III technical files to meet client needs.
Advised the new product development team through design control processes for the regula9on and control of Medical
Devices. Guided upda9ng of the Design Control System Life Cycle process for Medical Devices to meet the specified
requirements of ISO 13485, FDA 21 CFR part 820.30, and European MDD 93/42/EC. Direct experience with regulatory
standards, including FDA 21 CFR, ISO 13485, ICH Q-series, and EU MDR. An individual possessing a posi9ve outlook with
a good sense of humor, high values, enduring vision, strong work ethic, and unyielding integrity.More...