Principal Eng, Software

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Position Summary

The Principal Engineer Embedded Software Test is responsible for owning and driving the endtoend embedded software test strategy across programs and products. This role provides senior technical and execution leadership to ensure delivery of highquality compliant and reliable embedded software solutions in a regulated medical device environment.

The role partners closely with Software Engineering Program Management Architecture Quality Regulatory and external vendors to meet project objectives while advancing longterm organizational goals process maturity and agility.

Essential Duties and Responsibilities

• Own the endtoend embedded software testing strategy including test planning scheduling execution monitoring and reporting across global development teams.

• Lead manual and automated testing activities for embedded devices ensuring appropriate coverage across unit integration system and regression testing.

• Define and execute regression strategies riskbased testing approaches and defect prevention techniques.

• Apply Software FMEA regression analysis and risk management practices to ensure safety reliability and regulatory compliance.

• Collaborate closely with Program Managers Project Leads and Architects to achieve tactical project goals while balancing strategic software organization objectives.

• Provide technical leadership and mentorship to software and test teams distributed globally influencing development and verification practices across products.

• Support embedded software development and testability through strong knowledge of C C and Qt/QMLbased systems.

• Identify assess and manage project and technical risks driving mitigation plans and maintaining regular communication with stakeholders.

• Execute software programs using Agile / SAFe methodologies ensuring disciplined execution and predictable delivery.

• Act as a change agent driving agility continuous improvement simplification and a strong sense of urgency across teams.

• Ensure deployment of processes that assure conformance to the Baxter New Product Development (NPD) process including expedited yet compliant execution.

• Continuously review program progress proactively identify risks and collaboratively develop and drive risk mitigation efforts.

• Interact effectively with all levels of internal management crossfunctional partners and business units.

• Identify select manage and collaborate with external vendors providing specialized skills or services required for program execution.

• Participate in customer and regulatory interactions related to product design systems software processes and quality.

• Lead continuous improvement initiatives that may span multiple teams or departments to improve quality reliability cost and delivery efficiency.

• Contribute to and help develop longterm product development and technology plans.

• Prepare and deliver clear concise project status risk and quality reports to senior management using modern visualization and reporting tools.

Required Qualifications

• Bachelors or Masters degree in Computer Science Electrical Electronics Mechanical Biomedical Engineering or equivalent.

• Extensive experience in embedded software testing including both manual and automated testing of embedded devices.

• Strong experience with defect management tools and industrystandard SDLC tools and processes.

• Deep understanding and practical experience in SDLC implementation in complex regulated environments.

• Working knowledge of embedded software development using C C and Qt/QML technologies.

• Demonstrated experience executing projects using Agile and/or SAFe methodologies.

• Proven ability to identify manage and mitigate risks while maintaining transparent stakeholder communication.

• Strong facilitation influencing negotiation and decisiondriving skills.

• Excellent written verbal and presentation skills including experience reporting to senior leadership.

Preferred Qualifications

• Experience working on medical device or Healthcare IT products.

• Exposure to medical and healthcare standards such as HL7 and medical cybersecurity practices.

• Familiarity with medical regulatory standards including FDA ISO and 510(k) processes.

• Experience with medical device software development lifecycle (SDLC) practices.

• PMP certification or equivalent project management credential.

Key Competencies

• Technical Leadership

• RiskBased Thinking

• Quality & Regulatory Mindset

• CrossFunctional Collaboration

• Executive Communication

• Continuous Improvement

• Change Leadership

• Strategic Thinking with Strong Execution Focus

Equal Employment Opportunity

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race color religion gender national origin age sexual orientation gender identity or expression protected veteran status disability/handicap status or any other legally protected characteristic.

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If because of a medical condition or disability you need a reasonable accommodation for any part of the application or interview process please click on the link here and let us know the nature of your request along with your contact information.

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