DR Engineering Director

Major Accountabilities：

1. Comprehensively lead and manage the DR (Digital Radiography) R&D team include Hardware Engineering, System Engineering, System Control, define and execute the DR product R&D strategy and technology roadmap in alignment with company goals
2. Responsible for the full lifecycle management of DR New Product Development (NPD), from concept, system design, prototyping to design verification, regulatory registration, and mass production
3. Lead system-level architecture design and resolve critical technical issues, ensuring efficient integration and performance optimization among hardware, software, mechanical, and imaging chain systems
4. Collaborate closely with cross-functional teams including Marketing, Product Management, QA/RA, Supply Chain, and Manufacturing to ensure products meet customer needs and business objectives
5. Ensure all R&D activities strictly comply with medical device quality management systems and global regulatory standards (e.g., ISO 13485, FDA 21 CFR 820, NMPA, CE)
6. Monitor the latest industry technology trends (e.g., AI-assisted imaging, smart detectors, new materials), drive technical innovation, and enhance the core competitiveness of the product line
7. Responsible for organizational development and talent cultivation within the R&D team, building a high-performing and innovative engineering team through coaching and performance management

Requirement

1. Bachelor’s degree or above in Biomedical Engineering, Electrical Engineering, Mechanical Engineering, Physics or related fields; Master/Ph.D. preferred.
2. 15+ years of R&D experience in the medical device industry, with at least 10+ years of experience managing cross-functional R&D teams (Experience in large imaging modalities like DR, CT, MR is highly preferred).
3. Proficient in engineering principles for complex medical systems (Systems Engineering), with deep understanding of X-ray generation, flat panel detectors, and imaging chain technologies.
4. In-depth understanding of IEC 60601 standards, ISO 13485 QMS, and global regulatory requirements (FDA/NMPA/MDR).
5. Excellent cross-functional communication skills and global perspective; able to communicate and present fluently in English with global technical teams and senior executives.
6. Outstanding leadership and strategic thinking, capable of inspiring teams and resolving complex engineering and business conflicts.
7. Strong business acumen and technical passion for medical AI, automation, and digital transformation.
8. Strong analytical, strategic planning skills and business case analysis.
9. Complex Project Leadership - demonstrated ability to define initiatives and goals, drive execution, manage budgets, measuring performance against goals, and leading a diverse and fluid global team of 30+ people.
10. Global Leadership- driving change throughout the organization.