Sr. Software Quality Engineer

Job Description

Now’s our time to inspire the future of healthcare together.

Siemens Healthineers is a leading global medical technology company with over 170 years of experience and 18,000 patents. More than 60,000 dedicated colleagues in over 70 countries are driven to shape the future of healthcare. We stand with our customers around the world to support them in delivering high quality care to their patients. An estimated 5 million patients across the globe benefit every day from our innovative technologies and services in the areas of diagnostic and therapeutic imaging, laboratory diagnostics and molecular medicine, as well as digital health and enterprise services. This is what truly matters to us.

Join our team now at Siemens Healthineers as the Senior Software Quality Engineer (QE)

This is a role well suited to an ambitious professional, looking for the next step in their career. As an Sr. Software QE, you will be responsible for:

The Sr. Software Quality Engineer reports to Sr. Manager of Quality Engineering for Ultrasound Systems, Transducers and Catheters. This role is expected to actively participate and lead Cross Functional Teams throughout the Product Lifecycle with focus on Software Quality, Reliability, and Compliance. This role is responsible for Developing and Implementing Software Solutions and Tools covering SDLC practices and KPI Dashboards. This role is also responsible for guiding and serving as SME for SDLC practices, KPIs, DevTestOps Automation, Product and Non-Product Software Validation efforts. This role requires hands-on Software Design and Development background, SaMD and SDLC KPI expertise, Lean and Agile practices, Excellent cross functional leadership, and problem-solving skills.

The Sr. Software Quality Engineer core responsibilities:

  • Establish Software Quality Engineering (QE) vision, strategy and plan working 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 and other efforts
  • 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
  • Lead QE software projects communicating status, issues, risks and mitigation plan to stakeholders and senior leadership effectively in a timely manner

Minimum Requirements:

  • BS or MS in Software, Electrical Engineering or equivalent
  • Minimum 4 years of experience in Software Design and Development preferably in healthcare industry

·     Working knowledge of medical device software in adherence to ISO 13485/14971, IEC 62304/82304 standards + any other a plus

·     Ability to code (Python, JS, C/C++, SQL etc.), DICOM, DB, Network, Security experience a plus

·     Familiarity with DevTestOps technologies, infrastructure and tools, test automation a plus

·     Experience in Class II or III medical device preferred.

·     Clear Communication, Self-driven, Cross-Functional abilities in a global environment is a must.

·     Software Design and Development, Troubleshooting, RCA, CAPA a must

·     Experience with Med Device Design Controls, SDLC, Reliability and Risk Management a plus

Siemens Healthineers has recently announced the next steps in our continued commitment to prioritize colleague health, comply with customer/business partner requirements, and help preserve our business continuity.  Going forward, please be aware that Siemens Healthineers requires full COVID-19 vaccination for all new hires by their start date except where prohibited by state law.

(Note: Accommodations may be requested for certain medical or religious reasons)

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

If you want to join us in transforming the way healthcare is delivered, visit our career site at

If you wish to find out more about the specific before applying, please visit:

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


Organization: Siemens Healthineers

Company: Siemens Medical Solutions USA, Inc.

Experience Level: Experienced Professional

Job Type: Full-time

Equal Employment Opportunity Statement
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.

EEO is the Law
Applicants and employees are protected under Federal law from discrimination. To learn more, Click here.

Pay Transparency Non-Discrimination Provision
Siemens follows Executive Order 11246, including the Pay Transparency Nondiscrimination Provision. To learn more, Click here.

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