Do you want to join us in helpingto fight the world’s most threatening diseases and enabling access to care formore people around the world? At Siemens Healthineers, we pioneer breakthroughsin healthcare. For everyone. Everywhere.

　　At Siemens Healthineers, We offer you aflexible and dynamic environment with opportunities to go beyond your comfortzone in order to grow personally and professionally. Sound interesting? Thencome and join our global team as a Senior Manager of Quality Engineering.

　　The Senior Manager ofQuality Engineering (QE) is a staff level position reporting to the SeniorDirector of Quality Ultrasound Systems and Catheters. This position isresponsible for engineering quality systems pertaining to Advanced Technology& Development, New Product Introduction (NPI), and After Market Support incompliance with Siemens Healthineers Company Policies, Global Regulatory Requirements,Industry Standards and Best Practices with focus on Product Quality,Reliability, and Process Compliance.

　　This role will lead QE and Cross FunctionalTeams throughout the Product Life Cycle (PLC) helping deliver successful UltrasoundProduct Programs. This role will actively participate and lead Quality Projectsas part of Quality and Technology initiatives, influencing and drivingeffective implementation of PLC and SDLC best practices, ensuring PLC goals aremet.

　　The candidate must have a goodworking knowledge of medical device product life cycle in adherence to FDA QSR,EU MDR, MDSAP, ISO 13485, ISO 14971/24971, IEC 60601-1, IEC 62304 standards inaddition to other global medical device regulatory requirements.

　　Our global team: We are a team of more than 68,000 highly dedicated employeesacross more than 70 countries passionately pushing the boundaries of what’spossible in healthcare to help improve people’s lives around the world. As aleader in the industry, we aspire to create better outcomes and experiences forpatients no matter where they live or what health issues they are facing. Ourportfolio, spanning from in-vitro and in-vivo diagnostics to image-guidedtherapy and innovative cancer care, is crucial for clinical decision-making andtreatment pathways.

　　Our culture: We are part of an incredible community of scientists, clinicians,developers, researchers, professionals, and skilled specialists pushing theboundaries of what’s possible, to improve people’s lives around the world. We embrace a culture of inclusivity in whichthe power and potential of every individual can be unleashed. We spark ideasthat lead to positive impact and continued success. Check our Careers Site at https://www.siemens-healthineers.com/en-us/careers .

　　This is a role well suited to anambitious professional, looking for the next step in their career. As a SeniorManager of Quality Engineering , you will be responsible for:

　　Establish QE strategy and plan formanaging end-to-end product quality and process compliance throughout the productlife cycle of ultrasound systems, transducers and catheters.

　　Ensure compliance to DesignControls and SDLC throughout the development process, ensure robust assessmentof on-going issues, product changes, and monitoring of field performance.

　　Define and implement effective ProductQuality Plan with product quality and process compliance goals, CTQ metrics andmeasurements (KPIs), adherent to Design Controls, SDLC, Hazards and Risks, Defects,Complaints, Issue Investigations etc.

　　Mentor, and coach teams in thecreation of design and development plans, integration, verification andvalidation plans, software requirements specifications, design documents,design reviews, Risk Management File (RMF), test strategy, reports, andtraceability matrices.

　　Lead Continuous Improvement effortsacross the organization involving Quality System and Engineering procedures, processes,systems, and tools incorporating industry best practices.

　　Foster a culture of learning andsharing involving training and education of QMS, PLC, Design Controls, and SDLCframework.

　　Support Audits and Inspections asSubject Matter Expert (SME) of Product Program activities and deliverables involvingDesign Controls, SDLC, Verification & Validation, Defect Management, CAPA, RiskManagement and more.

　　Lead and manage Quality Engineeringteam with following responsibilities:

　　Responsible for oversight of productdesign, development and support activities across functional teams ensuring robustproduct milestone reviews in adherence to established Product Quality andProcess Compliance requirements.

　　Ensure proper issue investigationand timely resolution of defects originating from design verification,validation, customer complaints, and other improvement opportunities.

　　Actively engage Engineering, SupplierQuality, and Manufacturing teams addressing product and process validation needsincluding methodology, sample size determination, and ensure outcomes meetvalidation requirements.

　　Participate in product design and developmentactivities, including but not limited to review and approval of Requirementsand Specifications, Hazards and Risks analysis, Performance and Reliabilitymetrics, Design and Process FMEAs and more.

　　Participate in Product Milestones,Complaints, Defects, CAPA reviews, and Issue Investigations as part of ProductSteering Group member providing QE guidance.

　　Define and implement CTQs and KPIsworking closely with engineering ensuring CTQ/KPI dashboard driven decisionmaking and continuous improvement.

　　Represent QE in Product Programreviews, QMRs, Audits & Inspections. As SME provide organizationalleadership for Product Lifecycle Processes.

　　Required skills to have for thesuccess of this role:

　　Bachelor of Science degree inEngineering, Systems Engineering or related field.

　　5-10 years of experience as QE,QA, Product Program, Project Management in FDA QSR and EU MDR regulated medicaldevice industry.

　　Class II, III Medical Device, SiMD,Design Controls, SDLC, CAPA, Risk Management experience.

　　Clear Communicator able to Influenceand Lead in a Global Cross Functional Environment.

　　Experience in SoftwareDevelopment, Methodology, Software Quality, SDLC, KPIs is a plus.

　　Experience supporting issueinvestigations, audits & inspections, design reviews.

　　Strong Product Design,Development, Troubleshooting experience. Working knowledge of CAPA, riskmanagement, hazards analysis, corrections and recalls, defect management,complaint handling and statistical analysis techniques is a plus.

　　Experience applying ISO 13485,14971, IEC 62304, 60601-1 standards to a complex product. Able todemonstrate working knowledge of 21 CFR 820 compliant Quality System.

　　PMP, ASQ, CQE, Auditor experienceand certifications are a plus.

　　The pay range for this position is$130,000 - $155,000 annually; however, base pay offered may vary depending onjob-related knowledge, skills, and experience. The annual incentive target is 15%of base pay. Siemens Healthineers offersa variety of health and wellness benefits including paid time off and holidaypay. Details regarding our benefits can be found here: https://benefitsatshs.com/index.html

　　This information is provided perthe required state Equal Pay Act. Base pay information is based on marketlocation. Applicants should apply via Siemens Healthineers external or internalcareers site.

　　At Siemens Healthineers, we valuethose who dedicate their energy and passion to a greater cause. Our people makeus unique as an employer in the med-tech industry. What unites and motivatesour global team is the inspiration of our common purpose: To innovate for healthcare, building on ourremarkable legacy of pioneering ideas that translate into even betterhealthcare products and services. We recognize that taking ownership of ourwork allows both us and the company to grow. We offer you a flexible anddynamic environment and the space to move beyond your comfort zone to grow bothpersonally and professionally.

　　If you want to join us intransforming the way healthcare is delivered, visit our career site at https://jobs.siemens-healthineers.com/careers

　　If you wish to find out more aboutthe specific division before applying, please visit: https://usa.healthcare.siemens.com/about .

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　　Please beware of potentially fraudulentjob postings or suspicious recruiting activity by persons that are currentlyposing as Siemens Healthineers recruiters/employees. These scammers may attemptto collect your confidential personal or financial information. If you areconcerned that an offer of employment with Siemens Healthineers might be a scamor that the recruiter is not legitimate, please verify by searching for theposting on the Career site: https://jobs.siemens-healthineers.com/careers

　　“Successful candidate must be ableto work with controlled technology in accordance with US export control law.”“It is Siemens Healthineers’ policy to comply fully and completely with allUnited States export control laws and regulations, including those implementedby the Department of Commerce through the Export Administration Regulations(EAR), by the Department of State through the International Traffic in ArmsRegulations (ITAR), and by the Treasury Department through the Office ofForeign Assets Control (OFAC) sanctions regulations.”

　　As an equal-opportunity employerwe are happy to consider applications from individuals with disabilities.

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　　Siemens 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.

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