Senior Director Systems Development and Integration - Handheld Systems
Canadaw EPOCAL INC.
15+ YOECandidates need at least 15 years of product development leadership in medical devices or in vitro diagnostics, plus a systems engineering background. Knowledge of FDA regulations, ISO 13485 and 14971, and IVDD/IVDR compliance is required, and regular travel is expected.
Process improvement, Regulatory compliance, Firmware, Data management, Risk management, Leadership
Senior Director Systems Development and Integration - Handheld Systems
Canadaw EPOCAL INC.
15+ YOECandidates need a systems engineering degree, at least 15 years of medical device or diagnostics product development, and proven leadership of large, global teams. They also need working knowledge of FDA, ISO 13485 and IVDR rules.
Process improvement, Regulatory compliance, Firmware, Data management, Risk management, Leadership
Director of Assay Development and Consumables Integration - Handheld Systems
Canadaw EPOCAL INC.
12+ YOECandidates need at least 12 years of progressive experience in the IVD or medical device industry, including electrochemical sensor development, reagent chemistry, microfluidics and point-of-care product launches. Strong knowledge of FDA QSR, ISO 13485, IVDR and ISO 14971 is required, along with a bachelor's degree in a scientific or engineering field.
Process improvement, Leadership, Product comprehension, Data analysis, Hazard assessment, Regulatory compliance
Director of Assay Development and Consumables Integration - Handheld Systems
Canadaw EPOCAL INC.
12+ YOECandidates need at least 12 years of medical device or diagnostics experience, a bachelor's degree in a science or engineering field, and proven leadership of R&D teams. Hands-on skills in electrochemical sensors, reagent chemistry, microfluidics and high-volume plastic manufacturing are required.
Injection molding equipment, Automation equipment