Design Assurance Engineer

Job Title: Design Assurance EngineerLocation: NVIndustry: Medical DevicesJob SummaryWe are seeking a detail-oriented Design Assurance Engineer to support product development and lifecycle activities for medical devices. This role ensures design compliance with regulatory standards and internal quality systems, while collaborating cross-functionally to drive safe and effective product design.ResponsibilitiesSupport design control activities in compliance with FDA and ISO regulationsDevelop and maintain Design History Files (DHF) and technical documentationParticipate in risk management activities (FMEA, Hazard Analysis)Ensure compliance with ISO 13485, FDA 21 CFR Part 820, and other applicable standardsReview and approve design inputs, outputs, verification, and validation documentationSupport design verification & validation (V&V) activitiesCollaborate with R&D, Quality, Regulatory, and Manufacturing teamsParticipate in change control (ECO/ECN) processesAssist in audit readiness and regulatory inspectionsDrive continuous improvement in design and quality processesRequirements:Bachelor’s degree in Engineering (Mechanical, Biomedical, Electrical, or related)4–8 years of experience in medical device design assurance / quality engineeringStrong knowledge of design controls and risk managementExperience with FDA regulations and ISO 13485Familiarity with V&V processes and documentationUnderstanding of CAPA, change control, and quality systemsStrong analytical, documentation, and communication skillsPreferred:Experience with Class II or Class III medical devicesKnowledge of IEC 60601 / ISO 14971 standardsExposure to software or combination products is a plusCertification in quality (e.g., ASQ CQE) is an advantage