Senior Design Assurance Engineer - China

The  Health group is looking for a Senior Design Assurance Engineer to lead design assurance efforts for new product development projects. If you are passionate about the health space and want to have an incredible impact here at Apple, this could be the role for you. We are an efficient team who works closely together to establish relationships across multiple functional teams. We care deeply about getting amazing new products into our customers hands. Minimum Qualifications B.S. ME/EE/BME/CS degree or equivalent in any engineering/science discipline. 8+ years of experience in the medical device, biotechnology or pharmaceutical industry as a Design Assurance/Quality Engineer (SaMD AI/ML experience preferred). Demonstrated competency in international standards (ISO 13485, ISO 14971, IEC 62304, IEC 60601 and MDD/MDR) and U.S. FDA medical device regulations (21 CFR 820). Experience identifying and implementing novel design control frameworks in a fast paced medical device environment while ensuring compliance to relevant regulations and standards. Familiarity with software development practices and technical software development concepts and tools. Experience working with cross-functional teams comprising of various engineering disciplines. Strong organizational and management skills. Excellent communication skills, both verbal and written. Preferred Qualifications Experience working on software products within a quality or regulatory system. Expertise in execution of design controls. Proven background in being autonomous and being able to clearly work towards establish goals and initiatives with minimal oversight. Demonstrated competence in determination of appropriate global regulatory requirements for new products or product changes. Strong organizational and leadership skills. Excellent communication skills, both verbal and written.