Design Quality Engineer - Software Focus

We are seeking a Design Quality Engineer to support medical device development and sustaining projects, with a primary focus on product software. The engineer will help maintain design controls and risk management documentation, review software requirements and verification/validation evidence, and support traceability and Design History File (DHF) completeness. The role will work with R&D, Manufacturing, Regulatory, and Project Management to assess design changes, resolve quality issues, and support design transfer and regulatory submission readiness. The ideal candidate can take ownership of assigned work in a fast-paced environment, identify documentation gaps, and communicate clearly across functions.

Quality Engineering, Technical/Engineering Design, Quality Engineering, Engineering Software, Technical/Engineering Design, Medical Equipment, Project/Program Management, Documentation, Risk Management, Regulatory Submissions, Medical Device Software Quality: Direct experience supporting design quality or design assurance for software used in a regulated medical device. Design Controls and DHF: Experience reviewing design inputs/outputs, design documentation, and DHF records across development or sustaining projects. Software Verification and Validation: Experience reviewing software test protocols, results, and requirements-to-test traceability, and identifying gaps or unresolved issues. Risk Management: Experience with medical device risk assessments and FMEAs, including evaluating the effect of software or design changes on device safety and performance. Change Control and Quality Investigations: Ability to assess design change impacts and support related documentation, investigations, CAPA, and design transfer activities. Regulated Development: Working knowledge of medical device design controls and quality/risk management processes, including FDA requirements, ISO 13485, and ISO 14971. Communication and Execution: Ability to work independently, manage multiple priorities, follow through on commitments, and communicate progress and availability consistently. Benefits: This a contract position does not include employer-provided benefits., Applicants must be authorized to work in the United States