Teams at Profound Medical Corp.

Lead and maintain the production Quality Management System to ensure manufacturing, receiving, shipping, and reverse logistics meet regulatory and product specifications. Oversee incoming, in-process, and final inspections, testing, DHR/batch record review, release decisions, supplier quality, CAPA/RCA, audits, and test method validation while ensuring compliance with ISO 13485, FDA QSR, IEC standards, and related regulations.

Design and develop mixed-signal electronics for medical devices, own electrical specifications and verification, perform circuit analysis and simulation, debug system-level issues, guide PCB layout, bring up and characterize prototypes, and support design control, regulatory documentation, and manufacturing transfer.

Manage clinical trial operations from startup to closeout including site management, SIV/IMV/closeout visits, TMF maintenance, source data review/verification, safety reporting, site training, data and quality oversight, risk identification/mitigation, and regulatory/GCP compliance. Engage sites, review contracts/budgets/ethics submissions, and drive process improvements to ensure inspection-ready documentation and trial integrity.