Engineer IV/Complaint Analysts

Role: Engineer IV, Complaint Analysts at Takeda, responsible for leading engineering operations related to medical devices and combination products. Objectives include ensuring device quality, safety, reliability, and regulatory compliance through complaint handling, investigations, and design activities. Responsibilities encompass managing customer complaints, conducting laboratory evaluations, executing root cause analysis, supporting CAPA processes, and collaborating with external partners on technical issues. The role involves developing design verification protocols, ensuring compliance with medical device regulations, and leading technical project workstreams. Qualifications: Bachelor's degree in Engineering, Science, or related field; 2+ years relevant experience; proficiency in technical writing, risk management, and device testing; experience in regulated environments preferred. High-Value: Medical device focus, complaint management, root cause analysis, design verification, regulatory compliance, collaboration with external partners, and work in a controlled environment. Location: Lexington, MA; full-time, on-site with potential for shift work and safety protocols.