Engineer IV/Complaint Analysts

Role: Engineer IV, Complaint Analysts, managing engineering operations for medical device quality, compliance, and investigations. Responsibilities: analyze customer complaints, perform laboratory evaluations of returned devices, document investigations comprehensively, support CAPA activities, and lead technical project workstreams. Act as SME, liaise with external partners, and develop design verification protocols. Requirements: Bachelor’s in Engineering, Chemistry, Biology, or related field; 2+ years relevant experience; strong technical writing, collaboration, project management, and risk assessment skills. Preferred: experience in regulated lab/quality environments, and proficiency with design verification, risk management, and medical device regulations. High-Value: focus on medical devices, complaint handling, root cause analysis, risk evaluation, design verification, and cross-functional collaboration within a regulated environment. Work setup: based in Lexington, MA, with safety and compliance protocols for working in controlled environments; shifts may include weekends or additional hours.