Sr. Principal Engineer, PDO & Verification

Baxter International Inc.•Raleigh, NC

23h•$144,000 - $216,000

About The Position

This is where your work makes a difference. At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond. Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results. Here, you will find more than just a job—you will find purpose and pride. JOB LOCATION: Raleigh, NC POSITION: Sr. Principal Engineer, PDO & Verification POSITION DESCRIPTION: Baxter Healthcare Corporation is seeking a Sr. Principal Engineer, PDO & Verification with the following duties: Design and develop medical device systems and digital platforms, ensuring compliance with regulatory and business standards from concept to commercialization; Create and maintain product and software architecture, user interface design, and specifications that meet customer needs and regulatory requirements; Utilize systems engineering and design thinking to define functional and performance requirements for products and systems; Model behaviors across systems and conduct risk analysis from a systems perspective; Perform risk management activities, including analysis, evaluation, and mitigation, in accordance with ISO 14971; Develop and maintain verification and validation plans, test protocols, and reports to comply with FDA and industry standards; Conduct integration and system validation testing for Kubernetes-based digital platforms in On-Prem and Cloud environments; Prepare technical documentation (design plans, traceability matrices, test reports) in compliance with FDA-approved quality processes for Class I/II and MDDS products; Train and mentor the systems team.

Requirements

Bachelor’s degree in Electronics Engineering and Communications or related field plus 8 years of related experience
Will accept any level of experience in the following skills: Translate Customer/end user needs, design constraints, and regulatory mandates into comprehensive system requirements, including functional, non functional, and performance specifications for medical devices and health software
Perform comprehensive risk evaluation in compliance with ISO 14971, ensuring identification, analysis, and control of medical device risks
Analyze system behavior for complex medical products under FDA guidelines in accordance with IEC 60601-1 and IEC 80601-1 standards
Lead the verification and validation of medical devices and health software in strict accordance with IEC 62304 and IEC 82304, ensuring traceability, regulatory compliance, and adherence to FDA recognized software development lifecycle standards
Develop and maintain comprehensive verification and validation plans for medical devices and health software, including detailed test protocols, execution records, and test reports, ensuring full traceability, regulatory compliance with FDA requirements, and alignment with engineering best practices and standards such as 21CFR-820
Perform integration and validation testing of Kubernetes based medical device monitoring platforms across On Prem and Cloud, leveraging Docker, Kubernetes, MQTT, and RabbitMQ with secure API driven communication to ensure interoperability and compliance in regulated healthcare environments
Create and maintain regulatory compliant technical artifacts—including development plans, test protocols, traceability matrices, and verification/validation reports—in alignment with FDA requirements and medical device industry standards such as IEC 62304 and ISO 13485
Plan and prepare the test environment for integration of medical devices with Electronic Medical Record (EMR) systems, ensuring interoperability, data integrity, and patient safety in compliance with FDA regulations, IEC 62304 software lifecycle requirements, and HL7/FHIR interoperability standards
Expertise in IHE Patient Care Device (PCD) Alarm Communication Management Profile, which uses HL7 messaging standards to communicate between medical devices and alert management systems
Hands-on experience with PostgreSQL/MySQL clinical data repositories, ensuring precise data handling, integrity, and adherence to FDA and HIPAA regulations
20% international and domestic travel required to meet customers to understand user needs and clinical workflows

Responsibilities

Design and develop medical device systems and digital platforms, ensuring compliance with regulatory and business standards from concept to commercialization
Create and maintain product and software architecture, user interface design, and specifications that meet customer needs and regulatory requirements
Utilize systems engineering and design thinking to define functional and performance requirements for products and systems
Model behaviors across systems and conduct risk analysis from a systems perspective
Perform risk management activities, including analysis, evaluation, and mitigation, in accordance with ISO 14971
Develop and maintain verification and validation plans, test protocols, and reports to comply with FDA and industry standards
Conduct integration and system validation testing for Kubernetes-based digital platforms in On-Prem and Cloud environments
Prepare technical documentation (design plans, traceability matrices, test reports) in compliance with FDA-approved quality processes for Class I/II and MDDS products
Train and mentor the systems team

Benefits

Competitive compensation and benefits.
We understand compensation is an important factor as you consider the next step in your career.
At Baxter, we are committed to equitable pay for all our employees, and we strive to be more transparent with our pay practices.
To that end, this position has a base salary range of $144,000 - $216,000 plus an annual incentive bonus.
The above range represents the expected base salary range for this position.
The actual salary may vary based upon several factors including, but not limited to, relevant skills/experience, time in the role, business line, and geographic/office location.
Qualified applicants can apply directly to the Baxter Website at: jobs.baxter.com.
Please search job JR-199591.
EOE US Benefits at Baxter (except for Puerto Rico) This is where your well-being matters.
Baxter offers comprehensive compensation and benefits packages for eligible roles.
Our health and well-being benefits include medical and dental coverage that start on day one, as well as insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance.
Financial and retirement benefits include the Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount, and the 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching.
We also offer Flexible Spending Accounts, educational assistance programs, and time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave.
Additional benefits include commuting benefits, the Employee Discount Program, the Employee Assistance Program (EAP), and childcare benefits.
Join us and enjoy the competitive compensation and benefits we offer to our employees.
For additional information regarding Baxter US Benefits, please speak with your recruiter or visit our Benefits site: Benefits | Baxter 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.
Know Your Rights: Workplace Discrimination is Illegal 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.
Recruitment Fraud Notice Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information.
To learn how you can protect yourself, review our Recruitment Fraud Notice.
No matter your role at Baxter, your talent, skills, and time has a direct impact on people's lives.
Since 1931, we have been at the forefront of innovation by bringing smarter, more personalized care to patients around the world.
Now, we're more determined than ever to make a lasting impact as we are redefining healthcare delivery across the care journey.
Our Mission to Save and Sustain Lives motivates us as we create a culture in which each of us can succeed.
This is where you belong.