Chevis Dilbert, P.Eng. Email & Phone Number

Guelph, ON, CA

Mississauga, Ontario, Canada

• Planned, led and completed a MFDS Class III 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.
• Currently leading the sterilization validation and qualification for a local EO sterilizer for a single-use catheter

Mississauga, Ontario, Canada

• Planned, coordinated, and led a fast-paced, 2-year concept-to-commercialization project for a transseptal access solution with cross-functional team consisting of R&D, Process, Quality and Regulatory Affairs
• Led a team of R&D and Process engineers to complete design investigations and benchmarking activities, order critical components and tooling to de-risk the critical path of a transseptal access solution project
• Drove a cross-functional team to ensure the on-time delivery of an epicardial access solution, including stakeholder management, project timeline management, and identifying, communicating and managing project risks
• Completed risk management activities, such as Design FMEA (DFMEA) development, benefit-risk analyses (RBA), and implemented a Risk Management File (RMF) as per ISO 14971:2019 for the epicardial access solution
• Led a sprint team of engineers to design and complete compatibility investigations that assess the viability of three major, new product introduction (NPI) projects, as an input to leadership road-mapping activities
• Supported Regulatory Affairs with drafting technical responses to biocompatibility inquiries for a special 510(k)

Toronto, Canada Area

• Completed major design deliverables, including design investigations, components and product drawings, V&V activities, to enable development and commercialization of an updated transseptal access solution
• Evaluated the technical runway for a transseptal access solution, including concept generation, prototyping, manufacturing strategy, voice-of-customer (VOC) collection, and minimum viable product (MVP) identification
• Completed a 2-step tipping process project, including related process validation activities (i.e., IQ/OQ/PQ, TMVs)
• Supported continuous improvement activities for existing products by performing Root Cause Analysis (e.g. 6Ms, fault-tree analysis), providing corrective actions and completing engineering change orders (ECOs)

Toronto, Canada Area

• Conducted critical design investigations and reviews, and executed V&V activities to support the development and commercialization of the first commercially available all-in-one transseptal access solution (launched in.
• Implemented a leakage test protocol to streamline internal procedures, increase project efficiency and promote the adoptability of V&V test results between similar devices in order to reduce overall burden and lead.
• Designed and fabricated a 20+ component, die-forming tool for reinforced transseptal dilators in a single iteration using SolidWorks and performed engineering stack-up analyses to ensure fit, function and.
• Drafted DHF/DMR documentation for medical devices in accordance with ISO 13485:2016 and 21 CFR Part 820

Woodbridge, Ontario

• Drafted mass manufacturing process plans for production of drivetrain components using metal forming/cutting processes such as hobbing, shaper cutting, piercing and flow-forming
• Designed and implemented error proofing and gauging systems using tooling, gauges and vision sensors
• Utilized PFMEA, 8D and lean manufacturing principles for risk reduction on production lines
• Designed an equation-driven program management report template for communicating program status, timeline, CAPEX, tooling costs and project organization using Excel

Cayman Islands

• Repaired and carried out preventative maintenance on a variety of medical equipment
• Tested equipment to ensure personal safety and operational standards were met prior to operation
• Assisted with installation of medical devices, including anesthesia machine installation and HVAC system compatibility troubleshooting in surgical unit
• Performed workspace optimization to maximize efficiency and meet safety regulations

Cayman Islands

• Reviewed corporate documents, legal registrations and client due diligence for legal compliance
• Maintained document database consisting of 800+ client engagements regularly
• Compiled reports on client files and reported project status daily to Senior Corporate Administrator

Cayman Islands