Product Development Engineer

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