Kreg Therapeutics
The Electrical Service Technician is responsible for executing electrical safety and functional testing, servicing and repair of medical devices, and supporting production and engineering teams with electrical and electromechanical troubleshooting. This role plays a critical part in ensuring product compliance, supporting firmware deployment and validation efforts, and contributing to continuous improvement of documentation and processes.
Requirements
Electrical Safety Testing & Quality Assurance • Perform electrical safety tests (e.g., HiPot, Ground Bond/HiAmp, Leakage Current) in accordance with IEC 60601 standards and internal protocols. • Conduct bio-medical electrical inspections to ensure compliance with regulatory and quality standards. Repair & Servicing • Diagnose and repair electrical and electronic components of medical devices. • Support field returns and RMA processing with root cause analysis and rework documentation. Production Support • Troubleshoot and resolve electrical/electronic issues in production and manufacturing systems. • Perform firmware loading on finished goods and support final functional testing as needed. Firmware & Software Support • Assist with firmware validation and verification, including test setup, execution, and documentation. • Participate in regression testing and product configuration control during release cycles. Fixture and System Validation • Support validation of electro-mechanical test fixtures and automated testing systems. • Participate in IQ/OQ/PQ (Installation/Operational/Performance Qualification) of test and diagnostic equipment. Documentation & Process Improvement • Assist in updating and improving service procedures, test reports, work instructions, and technical documentation. • Maintain accurate records of tests performed, service logs, and quality data in accordance with ISO 13485 and FDA QSR requirements. Cross-functional Support • Collaborate with Engineering, Manufacturing, and Quality teams during product development, design changes, and CAPA investigations. • Support calibration and maintenance of test equipment and safety analyzers. Required Skills/ Job Requirements
Experience with ISO 13485, FDA 21 CFR Part 820, and product lifecycle documentation (V&V protocols, ECOs). Soldering and rework skills on SMT and through-hole components. Familiarity with automated test scripts or test management tools is a plus. Knowledge of ESD safety, lockout/tagout procedures, and workplace safety practices Qualifications
Associate's degree or technical diploma in Electronics, Electrical Engineering Technology, Biomedical Equipment Technology, or related field. Bachelor's degree is a plus. 2+ years of hands-on experience in electrical testing, service, or manufacturing support of medical or electronic devices. Familiarity with safety standards (IEC 60601, ANSI/AAMI ES60601-1) and test equipment (HiPot, DMM, Oscilloscope, Safety Analyzers). Experience with firmware flashing tools, serial communication protocols (UART, CAN, I2C), and embedded systems is a plus. Basic understanding of electro-mechanical systems and ability to read schematics and wiring diagrams. Strong documentation and communication skill Ability to work in a regulated environment and follow quality procedures precisely
Requirements
Electrical Safety Testing & Quality Assurance • Perform electrical safety tests (e.g., HiPot, Ground Bond/HiAmp, Leakage Current) in accordance with IEC 60601 standards and internal protocols. • Conduct bio-medical electrical inspections to ensure compliance with regulatory and quality standards. Repair & Servicing • Diagnose and repair electrical and electronic components of medical devices. • Support field returns and RMA processing with root cause analysis and rework documentation. Production Support • Troubleshoot and resolve electrical/electronic issues in production and manufacturing systems. • Perform firmware loading on finished goods and support final functional testing as needed. Firmware & Software Support • Assist with firmware validation and verification, including test setup, execution, and documentation. • Participate in regression testing and product configuration control during release cycles. Fixture and System Validation • Support validation of electro-mechanical test fixtures and automated testing systems. • Participate in IQ/OQ/PQ (Installation/Operational/Performance Qualification) of test and diagnostic equipment. Documentation & Process Improvement • Assist in updating and improving service procedures, test reports, work instructions, and technical documentation. • Maintain accurate records of tests performed, service logs, and quality data in accordance with ISO 13485 and FDA QSR requirements. Cross-functional Support • Collaborate with Engineering, Manufacturing, and Quality teams during product development, design changes, and CAPA investigations. • Support calibration and maintenance of test equipment and safety analyzers. Required Skills/ Job Requirements
Experience with ISO 13485, FDA 21 CFR Part 820, and product lifecycle documentation (V&V protocols, ECOs). Soldering and rework skills on SMT and through-hole components. Familiarity with automated test scripts or test management tools is a plus. Knowledge of ESD safety, lockout/tagout procedures, and workplace safety practices Qualifications
Associate's degree or technical diploma in Electronics, Electrical Engineering Technology, Biomedical Equipment Technology, or related field. Bachelor's degree is a plus. 2+ years of hands-on experience in electrical testing, service, or manufacturing support of medical or electronic devices. Familiarity with safety standards (IEC 60601, ANSI/AAMI ES60601-1) and test equipment (HiPot, DMM, Oscilloscope, Safety Analyzers). Experience with firmware flashing tools, serial communication protocols (UART, CAN, I2C), and embedded systems is a plus. Basic understanding of electro-mechanical systems and ability to read schematics and wiring diagrams. Strong documentation and communication skill Ability to work in a regulated environment and follow quality procedures precisely