Principal Eng, Software

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Position Summary

The Principal Engineer – Embedded Software Test is responsible for owning and driving the end‑to‑end embedded software test strategy across programs and products. This role provides senior technical and execution leadership to ensure delivery of high‑quality, 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 long‑term organizational goals, process maturity, and agility.

Essential Duties and Responsibilities

• Own the end‑to‑end 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, risk‑based 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/QML‑based 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, cross‑functional 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 long‑term 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

• Bachelor’s or Master’s 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 industry‑standard 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 decision‑driving 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

• Risk‑Based Thinking

• Quality & Regulatory Mindset

• Cross‑Functional 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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