Job Information
Siemens Medical Solutions USA, Inc. Senior Software Quality Engineer in Issaquah, Washington
DUTIES: Siemens Medical Solutions USA, Inc. is seeking a Senior Software Quality Engineer in Issaquah, Washington. Establish Software Quality Engineering (QE) vision, strategy and plan. Work closely with QE leader and Software Engineering Counterparts for implementing a robust SDLC based Software Quality, Reliability and Compliance program. Participate in product milestone reviews, Partner with other QE members in delivering Design Control and SDLC specific work items with software oversight. Serve as SME in providing SaMD based audit support, SDLC practices, tools and KPI guidance. Participate in software feature definition, design and development reviews ensuring clean transition from design input to development to test stage. Participate and guide engineering team with KPIs heatmap design and development effort. Participate in DevTestOps activities with the intent of improving and promoting CI/CT/CD practices. Familiarity with various integration and test levels, methods and automation. Provide Non-Product Software Validation guidance to DevTestOps. Perform RCA of software defects and complaints working closely with engineering team. Participate and assist in Defect Management, Complaint Handling, Risk Management, CAPA, FMEA, FTA, Software Safety Classification activities to ensure product quality & reliability. Ensure compliance to global SaMD regulations, company policies and procedures, industry standards and guidance throughout the product lifecycle helping assess and address change requests, issues, risks and monitor field performance. Conduct QE software projects communicating status, issues, risks and mitigation plan to stakeholders and senior leadership effectively in a timely manner. Qualifications:
The position requires a Bachelor's degree or foreign equivalent in Computer Science, Software Engineering, Electrical Engineering or a related field and four (4) years of experience in the job offered or as a Software Engineer or a related occupation. Alternatively, the employer will accept a Master's degree or foreign equivalent in Computer Science, Software Engineering, Electrical Engineering, or a related field and two (2) years of experience in the job offered, or as a Software Engineer or a related occupation. The position requires experience with the following: Software design and development; working knowledge of medical device software in adherence to ISO 13485/14971, IEC 62304/82304 standards; DevTestOps technologies, infrastructure and tools, and test automation; Med Device Design Controls, SDLC, Reliability and Risk Management; Experience with software design, review applicable code, test coverage etc.; Experience in SaMD (Software as a Medical Device) and SiMD (Software in a Medical Device) Design and Development, Implementation, Issue Investigation, Root Cause Analysis, Corrective Actions.