Hiring: Software Design Quality Engineer Company: Philips Location: Bedford, MA Job Posted Time: 2026-09-10 10:28:41 Employment Type: Full-time / On-site Target Skills & Keywords : Agile, C, C#, C++, Regulatory Compliance, SAFe About the job Experience: •5+ years’ experience in FDA regulated, IEC 62304 medical device software environments, with a focus on Software Design Assurance/Control, detailed knowledge of Risk Management (ISO 14971), SDLC and strong Understanding of all aspects of the QMS related to Software Design Controls. Required Skills: •Responsible for developing, maintaining, and managing comprehensive software quality documentation, ensuring their accuracy and regulatory compliance throughout the software lifecycle. •Leads the assessment of software designs by reviewing test and performance data to uphold quality, safety, and regulatory standards, and address any engineering deficiencies. •Lead in the effective application, compliance, and continuous improvement of policies, procedures, and practices related to software development and validation including- Software design/verification, Risk management, Systems validation, Traceability and Cyber security risk management. •Track and risk assess software Anomalies for pre- and post-market medical device software. •Conducts detailed root cause analyses for software quality issues and validating key design inputs like usability, reliability, and performance. •Assess products and systems to identify defects, abnormalities and design flaws by authoring and executing software test protocols and generating test reports. •Implements software quality plans and risk management activities, utilizes post-market analytics to monitor software performance, and initiates corrective actions as needed. •Ensure compliance across the product software lifecycle by overseeing regulatory planning and execution for new products and changes as well as managing filings and approvals by overseeing preparation and submission of documentation for global registrations to enable timely market access. Compensation: •$102,480 - $163,968 / year Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!