A company is looking for a Product Development Engineer. Key Responsibilities Refine existing product documentation and ensure regulatory compliance Draft and maintain design history file (DHF) content and support risk analysis Collaborate with cross-functional teams to define testable requirements and support V&V protocol development Required Qualifications 5+ years of experience in system design within a multi-disciplinary organization Experience with software as a medical device (SaMD) concepts Familiarity with ISO 14971 and IEC 62366 Bachelor's degree in engineering or a science-related field; biomedical engineering preferred Experience in a regulatory environment with strict compliance
Product Development Engineer • Sunnyvale, California, United States