Chevis Dilbert
Technical Project Manager @Profound Medical Inc.
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WORK HISTORY
Technical Project Manager @Profound Medical Inc.
Mississauga, ON, CA
Planned, led and completed a MFDS Class regulatory submission, including the completion of gap assessments, coordination of external product testing, and managed external communication with submission consultants• Leading an improvement project for a HIFU transurethral ablation catheter, including project planning activities, project risk management, and delivery of phase gate review meetings• Led a critical investigation to identify and eliminate the causes of system occlusion detection failures, resulting in software changes to improve occlusion detection and ensure forward compatibility with future designs• Providing technical guidance to projects by completing regulatory impact assessments per FDA 510(k) and Health Canada guidelines, creating action plans for design investigations, planning and coordinating V&V activities identifying, reviewing and citing relevant standards, and supporting requirement and protocol improvements• Currently leading the sterilization validation and qualification for a local EO sterilizer for a single-use catheter
EDUCATION
University of Toronto
Bachelor of Applied Science (BASc), Mechanical Engineering
SKILLS
ABOUT CHEVIS DILBERT
Medical Device Project Manager | ISO 13485 & 21 CFR 820 Compliance | Expertise in Design Control, Risk Management, and Product Delivery | Driving Excellence in Medical Device Development
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