Job Overview

We are seeking a highly skilled and hands-on Systems Engineer to join our team in developing advanced catheter-based medical devices that integrate with energy-based therapeutic systems. The ideal candidate will have extensive experience with electromechanical systems (i.e. RF ablation generators, pulsed-field ablation generators) or other energy-based therapeutic devices. This role requires familiarity with IEC 60601-1 and 60601-1-2 testing, electro-mechanical system development and troubleshooting, and proprietary test method design, development, and validation. The candidate should also be proficient in MATLAB, Python, or an equivalent software for instrument control, data analysis, and system modeling.

This position involves working closely with cross-functional teams to ensure the successful integration, testing, and validation of complex medical device systems. The role is critical to ensuring compliance with regulatory standards and delivering high-quality, innovative solutions to improve patient outcomes. This is an onsite position working out of Santa Clara, CA.

Key Responsibilities

System Testing & Validation

• Develop, document, and execute test protocols for system-level and component-level testing of Class II and III medical devices. This requires a thorough understanding of measurement system principles (sampling rates, accuracy, precision, resolution, dynamic range, etc.).
• Oversee IEC 60601-1 (medical equipment electrical safety) and 60601-1-2 (medical equipment electromagnetic compatibility) compliance testing.
• Troubleshoot and resolve issues in electromechanical system performance and operation, including hardware, software, and firmware components.

Data Analysis & Reporting

• Analyze test data using MATLAB, Python, or equivalent software-based analysis tools to ensure device performance meets specifications. Processing, analysis, and interpretation of data may require development and validation of custom-written software analytical methods.
• Generate detailed test reports, including statistical analyses, and provide recommendations for design improvements.
• Compile assumptions, experimental details, analytical methods, results, and interpretation into presentable formats (reports and presentations) for review by both technical and non-technical audiences

System Integration

• Collaborate with R&D, quality, and regulatory teams to integrate catheter, hardware, software, and firmware components into a cohesive system
• Support the development of system and security architectures and ensure compatibility and proper operation between subsystems.

Regulatory Compliance & Documentation

• Ensure all testing and development activities comply with FDA, ISO 13485, and EU MDR standards.
• Contribute to the creation and maintenance of design verification and validation documentation, risk management files, usability engineering files, and traceability matrices.
• Cross-Functional Collaboration
• Work closely with design, manufacturing, and quality teams to ensure seamless product development and testing processes.
• Provide technical expertise and technical writing skills to support regulatory submissions and audits.

Qualifications

Education

• Minimum of Bachelor’s degree in Electrical Engineering, Biomedical Engineering, or a related field. Equivalent work experience will also be considered.

Experience

• Minimum of 5 years of experience in systems engineering, test engineering, or a related role within the medical device industry.
• Proven experience working with medical devices that integrate disposables, mechanical, electrical, software, and firmware components, particularly catheter-based systems or energy-generating therapeutic devices.
• Hands-on experience with IEC 60601-1 and 60601-1-2 testing and compliance.

Software Proficiency

• Strong proficiency in MATLAB, Python, or equivalent software for instrument control, data analysis, and system modeling. Must be capable of developing custom-written software tools for data acquisition, processing, analysis, and interpretation.
• Familiarity with electronic document management tools (e.g., MasterControl, Windchill) is a plus.

Technical Expertise

• In-depth knowledge of electronic systems, including hardware and software integration.
• Excellent problem-solving skills, with the ability to troubleshoot electromechanical systems and provide practical solutions.

Regulatory Knowledge

• Familiarity with FDA 21 CFR 820, ISO 13485, and EU MDR requirements.
• Familiarity with 60601-1 and 60601-1-2 compliance standards and requirements for medical electrical equipment

Communication & Collaboration

• Excellent written and verbal communication skills for creating clear and concise technical documentation.
• Strong ability to work in a cross-functional team environment.

Preferred Qualifications

• Experience with energy-based therapeutic devices or other Class III medical devices.

Why Join Us?

• Be a key contributor to the development of life-saving medical technologies.
• Collaborate with a talented, multidisciplinary team in a highly innovative and regulated environment.
• Competitive salary and benefits package, with opportunities for professional growth and development.