Principal Design Quality Engineer - Cardiology

Principal Design Quality Engineer focusing on active implantable medical devices. Partners with R&D, process development, manufacturing, and regulatory affairs to ensure product and processes remain safe, high-quality, and compliant throughout the lifecycle. Responsibilities include applying systematic problem-solving to quality issues, supporting DA activities related to risk management, design controls, and post-market priorities, developing and maintaining documentation (including Design History File, product specifications, and risk tools like FMEAs and hazard analyses), validating and verifying products, and collaborating with cross-functional teams to implement design controls and value-improvement initiatives. Requires a bachelor’s degree in a related field and 9+ years of design assurance or regulated medical-device experience; strong written and verbal communication; ability to work in a hybrid onsite/remote environment; and knowledge of quality tools and regulatory requirements (ISO 13485, ISO 14971). Preferred qualifications include experience with medical electrical equipment/active implantables and design controls/risk analysis understanding.