Senior Software Design Quality Engineer (Medical Devices SaMD)
# Senior Software Design Quality Engineer (Medical Devices SaMD) **Systems Ally** · Carlsbad, CA 92011 · `On-site` 🕒 **Статус:** *Опубликовано: вчера* · *Источник: Indeed* --- ### About the Role MUST have SaMD, IEC 62304 exp. We are looking for multiple Senior Software Quality Engineer with hands-on medical device industry experience to support the development and lifecycle management of regulated medical device software, SaMD, connected devices, and wearable medical products. This is not a general software QA, SaaS QA, or IT software quality position. Candidates must have direct experience working in a regulated medical device environment and applying medical-device software quality, design controls, risk management, and verification/validation requirements. The ideal candidate has worked closely with Software Engineering/R&D, Systems Engineering, Quality, Regulatory, and Risk Management teams and understands how software development activities integrate with the medical device product development process. Responsibilities: Provide software quality oversight throughout the medical device software lifecycle , from requirements and architecture through verification, validation, release, and post-market activities. Ensure software development activities comply with applicable medical device regulations, standards, procedures, and design controls. Apply and interpret IEC 62304, ISO 14971, ISO 13485, FDA 21 CFR Part 820/QMSR , and applicable FDA software guidance. Support software quality activities for SaMD, embedded software, connected medical devices, wearable devices, and/or cloud/mobile components associated with medical devices . Review and approve software development and quality documentation, including: Software Development Plans Software Requirements Specifications (SRS) Software Architecture and Design Documentation Software Risk Assessments Software FMEA / DFMEA Hazard Analysis and Risk Management Files Software Verification & Validation Plans and Protocols Test Cases, Test Results, and Reports Traceability documentation Software Release and Change Control documentation Work with Software Engineering and Systems Engineering to ensure user needs → system requirements → software requirements → implementation → verification/validation are appropriately linked and documented. Participate in medical device software risk management , including identification of software-related hazards, hazardous situations, failure modes, causes, risk controls, and verification of risk-control effectiveness. Review software verification and validation strategies, test protocols, test cases, results, deviations, anomalies, and defect assessments. Evaluate software development processes and records for compliance with internal procedures and applicable regulatory requirements. Support software-related CAPA, nonconformance, complaint, change control, and defect investigation activities. Support cybersecurity activities for medical device software, including review of cybersecurity-related risks, controls, requirements, verification, and documentation. Collaborate with R&D, Software Engineering, Systems Engineering, Product Quality, Regulatory Affairs, Clinical, Manufacturing, and other cross-functional teams . Support regulatory submissions and remediation activities involving medical device software, including 510(k), PMA, EU MDR, and other international submissions , as applicable. Participate in internal audits, supplier assessments, FDA inspections, Notified Body audits, and MDSAP activities related to software quality. Review software and computerized systems used in manufacturing, testing, service, and product support from a regulated quality perspective. Support design transfer and product lifecycle activities to ensure appropriate software and system quality controls are maintained through production and post-market phases. Analyze software quality data, defects, trends, and recurring issues and support continuous improvement activities. Required Medical Device Experience Candidates should have direct hands-on experience in medical device product development or quality engineering , preferably involving Class II or Class III products . Required experience includes: 5+ years of experience in software quality engineering within the medical device industry Direct experience applying IEC 62304 to medical device software Hands-on experience with ISO 14971 medical device risk management Experience with medical device design controls and software lifecycle documentation Experience reviewing or approving medical device software requirements, architecture/design, risk documentation, and V&V documentation Experience with software verification and validation in a regulated medical device environment Working knowledge of ISO 13485 and FDA 21 CFR Part 820/QMSR Experience working with Software Engineering/R&D teams on regulated medical device products Understanding of the relationship between software requirements, system requirements, risk controls, and verification/validation Experience supporting regulatory or quality activities for commercial or pre-market medical device products Preference will be given to candidates with experience in one or more of the following: Software as a Medical Device (SaMD) Wearable medical devices Connected medical devices Embedded medical device software Cloud-connected medical devices Mobile medical applications Electromechanical medical devices with embedded software Class II/III medical devices Combination products with significant software components Additional Preferred Experience Medical device cybersecurity and FDA cybersecurity expectations FDA 510(k) or PMA submissions involving software EU MDR technical documentation involving medical device software AAMI TIR57/TIR97 or related medical device cybersecurity practices Software FMEA / DFMEA and software-related hazard analysis Traceability and requirements management Software anomaly/defect investigation Medical device CAPA and nonconformance investigations Experience interacting with FDA, Notified Bodies, or MDSAP auditors Experience with regulated computerized systems used in manufacturing, laboratories, quality, or product support ASQ CSQE, RAC, or related quality/regulatory certification Education Bachelor's degree in Software Engineering, Computer Science, Biomedical Engineering, Electrical Engineering, Systems Engineering, or a related technical discipline Master's degree is a plus Medical Device Software Quality Engineer | Software Quality Engineer – Medical Devices | Software Quality / Design Quality Engineer | SaMD Quality Engineer | Medical Device Software Validation | Software Quality Assurance – Medical Devices | Product Quality Engineer – Medical Devices Pay: $40.00 - $60.00 per hour Work Location: In person
Наблюдалась 2026-09-21, впервые 2026-09-20, источник — Indeed.