We are actively seeking a System Engineer who will be responsible for the architecture, design, integration, and technical leadership of high‑power X‑ray generator systems ranging from 20 kW to 150 kW and beyond. This role drives system‑level requirements, design decisions, risk management, verification, and regulatory compliance throughout the product lifecycle. The successful candidate will possess deep expertise in high‑voltage power electronics, medical imaging systems, and multidisciplinary product development.

Systems

Engineering & Requirements Management Develop, maintain and manage system requirements, architecture, performance specifications, and technical roadmaps for high‑power X‑ray generator platforms.

Interface Control

Documents (ICDs) Risk management documentation Establish requirement traceability from customer needs through verification and validation activities. Participate in product planning, design reviews and change control processes. Develop and maintain system‑level designs encompassing AC/DC power conversion systems, high‑frequency inverter topologies, high‑voltage transformers and insulation systems, voltage multiplier networks, filament power supplies, AC drive systems, and energy storage and discharge systems.

Allocate and trace system requirements across electrical, firmware, software and mechanical subsystems. Lead system‑level trade studies balancing performance, reliability, safety, manufacturability, serviceability and cost. Support technology selection, platform architecture decisions and product roadmap planning.

Optimize efficiency, thermal performance, power density, reliability and long‑term robustness. Define tube protection algorithms, fault detection methods and exposure control strategies. Ensure compliance with image quality,



dose accuracy and exposure repeatability requirements.

Regulatory

Compliance & Quality Support product compliance with applicable standards and regulations, including IEC 60601 Series, IEC 61000 EMC Standards, IEC/EN 62304 Medical Software Lifecycle Processes, ISO 14971 Risk Management, FDA Quality System Regulations (21 CFR Part 820) and EU MDR. Participate in regulatory audits, technical file reviews and design control activities. Collaborate with quality, regulatory and clinical teams to ensure compliance throughout the product lifecycle.

Lead and support Design Verification Testing, Design Validation Testing, Environmental Qualification Testing, Reliability and Life Testing, Safety Testing, EMC/EMI Compliance Testing and System Integration Testing. Review test results and drive resolution of technical issues. Risk Management & Reliability Engineering Participate in PFMEA and manufacturing risk reviews.

Identify

Critical‑to‑Quality (CTQ) and Critical‑to‑Safety (CTS) characteristics. Support fault‑tree analysis, hazard analysis and system safety assessments. Bachelor's degree in Electrical Engineering, Electronics Engineering, Physics, Systems Engineering or a related technical discipline. Master's degree & PENG preferred. Minimum 8 years of experience developing high‑power electronic systems.

Experience with medical imaging, industrial imaging,



security imaging or other high‑voltage equipment is highly preferred. Strong understanding of high‑voltage power electronics and power converter design. Familiarity with medical device design controls and regulated product development processes.

Experience with requirements management and systems engineering methodologies. Knowledge of reliability engineering, risk management and root‑cause analysis techniques. Familiarity with fluoroscopy, radiography, CT or industrial imaging systems. Knowledge of IEC 60601, ISO 14971, IEC 62304 and FDA/MDR regulatory requirements.

Experience with model‑based systems engineering (MBSE) tools and methodologies. Project leadership or technical lead experience in complex multidisciplinary systems.

We offer an attractive compensation package with competitive salaries and comprehensive benefits, including health and wellness programs, career development, generous retirement savings plan with company match and more. CPI is committed to providing equal employment opportunities for all current and prospective employees, and to promoting a culture of inclusion and respect for everyone. We celebrate the innovation that diversity creates in the work workplace, and we recognize that each employee brings their own unique capabilities, experiences and perspectives to the organization.

We do not discriminate based upon race, religion, color, national origin, sex (including pregnancy, childbirth or related medical conditions), sexual orientation, gender, gender identity, gender expression, transgender status, sexual stereotypes, age, status as a protected veteran, status as an individual with a disability or other applicable legally protected characteristics. #

📌 Electronics System Engineer - High Voltage Power (Campbellville)
🏢 Communications u0026 Power Industries (CPI)
📍 Campbellville