Senior Software Quality Engineer

Company:Siemens Medical Solutions USA, Inc.Location: 22010 South East 51st Street,Issaquah, Washington 98029Position Title: Senior Software Quality EngineerHours: Monday – Friday, 8:00 amto 5:00 pm, 40 Hours/ WeekSummaryof Duties: Establish Software QualityEngineering (QE) vision, strategy and plan.Work closely with QE leader and Software Engineering Counterparts forimplementing a robust SDLC based Software Quality, Reliability and Complianceprogram. Participate in product milestone reviews, Partner with other QEmembers in delivering Design Control and SDLC specific work items with softwareoversight. Serve as SME in providingSaMD based audit support, SDLC practices, tools and KPI guidance. Participatein software feature definition, design and development reviews ensuring cleantransition from design input to development to test stage. Participate andguide engineering team with KPIs heatmap design and development effort.Participate in DevTestOps activities with the intent of improving and promotingCI/CT/CD practices. Familiarity with various integration and test levels,methods and automation. Provide Non-Product Software Validation guidance toDevTestOps. Perform RCA of software defects and complaints working closely withengineering team. Participate and assist in Defect Management, ComplaintHandling, Risk Management, CAPA, FMEA, FTA, Software Safety Classificationactivities to ensure product quality & reliability. Ensure compliance toglobal SaMD regulations, company policies and procedures, industry standardsand guidance throughout the product lifecycle helping assess and address changerequests, issues, risks and monitor field performance. Conduct QE softwareprojects communicating status, issues, risks and mitigation plan tostakeholders and senior leadership effectively in a timely manner.Qualifications:Theposition requires a Bachelor’s degree or foreign equivalent in ComputerScience, Software Engineering, Electrical Engineering or a related field andfour (4) years of experience in the job offered or as a Software Engineer or arelated occupation. Alternatively, the employer will accept a Master’s degreeor foreign equivalent in Computer Science, Software Engineering, ElectricalEngineering, or a related field and two (2) years of experience in the joboffered or as a Software Engineer or a related occupation. The positionrequires 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 RiskManagement; Experience with software design, review applicable code, testcoverage etc.; Experience in SaMD (Software as a Medical Device) and SiMD(Software in a Medical Device) Design and Development, Implementation, IssueInvestigation, Root Cause Analysis, Corrective Actions.Equal Employment Opportunity StatementSiemens is an Equal Opportunity and Affirmative Action Employer encouraging diversity in the workplace. All qualified applicants will receive consideration for employment without regard to their race, color, creed, religion, national origin, citizenship status, ancestry, sex, age, physical or mental disability unrelated to ability, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender, sex stereotyping, order of protection status, protected veteran or military status, or an unfavorable discharge from military service, and other categories protected by federal, state or local law.Reasonable AccommodationsIf you require a reasonable accommodation in completing a job application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please fill out the accommodations form by clicking on this link Accommodation for disability form If you’re unable to complete the form, you can reach out to our AskHR team for support at 1-866-743-6367. Please note our AskHR representatives do not have visibility of application or interview status.EEO is the LawApplicants and employees are protected under Federal law from discrimination. To learn more, Click here.Pay Transparency Non-Discrimination ProvisionSiemens follows Executive Order 11246, including the Pay Transparency Nondiscrimination Provision. To learn more, Click here.California Privacy NoticeCalifornia residents have the right to receive additional notices about their personal information. To learn more, click here.