Lead electrical system and subsystem design for medical devices.
Translate user, clinical and business requirements into system specifications.
Design electrical schematics, PCB layouts and supporting documentation using ECAD tools.
Develop analog, digital, power supply, isolation and signal conditioning circuitry.
Design and validate embedded control systems, motor controls and power delivery systems.
Collaborate with firmware and software engineers.
Support sensor integration and communication interfaces (USB, HDMI, Ethernet, wireless/RF).
Lead verification, validation and testing activities.
Conduct electrical and functional testing using laboratory instruments.
Ensure compliance with IEC 60601, EMC/EMI and other applicable standards.
Lead design FMEAs, risk assessments and hazard analyses.
Maintain Design History Files (DHF) and technical documentation.
Support regulatory submissions including 510(k) and CE Mark documentation.
Work with third-party testing laboratories.
Mentor junior engineers and technicians.
Lead root cause analysis and corrective actions.
Ensure compliance with ISO 13485 and company quality systems. [Manpower R...ctrical_V1 | PDF]
Requirements
Education
Bachelor's degree in Electrical Engineering, Electronics Engineering, Computer Engineering or related field. [Manpower R...ctrical_V1 | PDF]
Experience
6 to 9 years of experience in electrical design, embedded systems or R&D engineering.
Medical device industry experience is highly desirable, particularly surgical, endoscopic, imaging or electromechanical products. [Manpower R...ctrical_V1 | PDF]
Skills
Schematic capture, PCB layout and ECAD tools.
Analog, digital, mixed-signal and embedded systems design.
Use of oscilloscopes, logic analysers, spectrum analysers and multimeters.
Motor control, power delivery and sensor integration.
Communication protocols such as USB, HDMI, Ethernet, CAN, SPI and I2C.
Knowledge of IEC 60601-1, IEC 60601-1-2, ISO 14971 and FDA 21 CFR 820.
Knowledge of 510(k), CE Mark and global medical device regulations.
Strong written and verbal communication skills.
Root cause investigation and problem-solving capabilities.