Microscopic Imaging System Developer
2 days ago
Product Development Opportunity
We are seeking a highly skilled and experienced Product Engineer to join our team. As a Product Engineer, you will play a key role in developing and enhancing sophisticated microscopic systems for next-generation medical imaging products.
Key Responsibilities:
- Maintain and develop company's flagship microscopic imaging products. In charge of Electrical/Electronic system design, develop schematics, PCB layouts, and firmware integration for new products, focusing on power distribution, signal integrity, and hardware-software interfacing (e.g., actuators, I/O control, signal processing)
- Partner with software, mechanical, and QA teams to resolve integration issues and drive cost/quality improvements continuously to ensure robust system integration and safety as per the requirement of ISO14971, ISO/IEC 61010/60101, FCC etc. for compliance
- Create and maintain comprehensive engineering documentations adhering to good documentation practice (GDP) and regulatory standards such as ISO 13485 and ISO 14971
- Diagnosis on electrical/electronic failures (e.g., PCB, power circuits, communication interfaces), implement root-cause solutions, perform hands-on system configuration, buyoff testing, commissioning/decommissioning, verification, calibration, service, and maintenance to ensure optimal system performance and minimum operational downtime
- Provide trainings on troubleshooting methodologies and compliance practices
- Other duties as assigned
Requirements:
- Bachelor's/Master's in Electrical Engineering, Electronics, or related field
- 5+ years in electrical/electronic product development, including schematic design (Altium, Cadence), PCB layout, and prototyping
- Proven track record in troubleshooting complex hardware systems (e.g., power supplies, I/O control, embedded controllers)
- Experience documenting DHF, risk management files, and test reports with working knowledge of ISO 13485/9001, ISO 14971, IEC 62304, IEC 61010, FCC standards
- Strong project management, hands-on engineering skills, communication, and problem-solving abilities
- Excellent written/verbal communication skills. Proactive, results-driven, and able to work effectively and independently with minimum supervision
- Willingness and ability to travel (
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