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Senior Principal Software Quality Engineer (Hybrid)

Req #: JR - 073602 Location Deerfield, Illinois, United States Job Category: Engineering Date Posted: 08/03/2022

Overview

Being an Engineer at Baxter means you play a critical role in helping us achieve our mission to save and sustain lives. From innovative product design through to production and patient delivery, our Engineers are key to delivering results for our customers and patients worldwide.

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    Well-Being Benefits

  • Paid Time Off

  • 2 Days a Year to Volunteer

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Success Profile

What makes a successful Engineer at Baxter? Take a look at some of the top traits we’re looking for and see if you’re a fit.

  • Problem Solver
  • Analytical Thinker
  • Data Driven
  • Solution Focused & Results Oriented
  • Collaborative
  • Innovative

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Senior Principal Software Quality Engineer (Hybrid)

This is where you save and sustain lives

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You’ll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients. 

Baxter’s products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work. 

Join us at the intersection of saving and sustaining lives— where your purpose accelerates our mission. 

The Senior Principal Software Quality Engineer position falls within a new and growing team - Digital Health & Apps. This person will work as a member of one or more cross-functional product development teams by being engaged in new product development and/ or sustaining products covering emerging technologies such as Digital Health, Health Software, Software as a Medical Device (SaMD) and Clinical Decision Support (CDS).

This individual will serve as a quality representative on the software project team and will work closely with the Core Team Leader. This role is responsible for ensuring that each project is developed and released meeting customer expectations and in compliance with Baxter’s software lifecycle management policies and procedures.

This Senior Principal Engineer will work closely with product engineering to ensure robust requirements, successful design, development, verification and validation testing, design transfer and change control management. In addition, this individual will provide support to product software sustaining engineering and support the creation of regulatory submission documentation.

Qualifications

  • Experience in assessing and developing procedure to meet Digital Health regulatory requirements and guidance’s.
  • Experience with FDA inspections. ISO/ Notified Body audits is a plus.
  • Experience in the application of design controls and compliance requirements in accordance with 21 CFR Part 820, 803, & 806, IEC 62304, ISO 13485, ISO 14971, EU MDR, 21st Century Cures Act, NIST Cybersecurity framework, FDA pre and post market cybersecurity guidance, AGILE SDLC for the development of  SaMD/CDS and Health Software products.
  • Professional certification such as ASQ, IEEE, Six Sigma, LEAN manufacturing or achievement of certification.  ASQ CSQE preferred.
  • Strong communication and leadership skills.
  • Strong, results driven, project management skills.
  • Excellent problem-solving skills and the ability to teach others.
  • Capable of clearly presenting and justifying quality position and requirements to management.

Educational Requirements

  • Bachelor’s degree in Engineering or Computer Science with a minimum 8 years of experience or MS Engineering with minimum of 6 plus years of experience or Ph.D. Engineering with 3 years of experience in a highly regulated industry such as FDA, DoD, aerospace, telecom, or nuclear with a thorough understanding of the regulations, standards, Software Development Life Cycle (SDLC) and quality management systems.

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#IND-USOPS

The successful candidate for this job may be required to verify that he or she has been vaccinated against COVID-19, subject to reasonable accommodations for individuals with medical conditions or religious beliefs that prevent vaccination, and in accordance with applicable law.

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.

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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.

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Hear from Our Employees

Our company is enriched by a diverse population of individuals in more than 100 countries that work to solve, innovate, manufacture and drive better healthcare options for patients around the world.

Meet Anwesha – recently promoted to Manager, she leads a team of software engineers for our Medication Delivery business.

“I grew up in a small coastal town in India called Bhubaneswar, where we have our own traditions and culture. I think this has helped me grow personally and professionally. Working with a global team at Baxter, my background helps me to be open, appreciate and relate to people from all different places.”

Meet Sam – he has been with Baxter for over 15 years, working as an Engineering Technologist in Round Lake, IL, US.

“I have a wonderful team. They have been flexible and open to the differences in communication methods and work style necessary for me to excel. If I didn’t have that support, I wouldn’t be where I am now and I wouldn’t have been able to advance within the company. I’m proud to work at Baxter.”

Meet Erika – she has been an engineer in Round Lake, IL, US for over four years, promoted to Senior Principal Engineer in 2019.

“My involvement with National Society of Black Engineers outside of work has afforded me the opportunity to manage Baxter’s external partnership with the organization, exposing us to networking and talent that can help drive diversity and innovation, and providing opportunities for more community engagement and involvement, which I know a lot of my colleagues like.”

Quotes

Our company is enriched by a diverse population of individuals in more than 100 countries that work to solve, innovate, manufacture and drive better healthcare options for patients around the world.

Meet Sarah – (center) with members of the Baxter Engineering team who initiated a corporate partnership with Society of Women Engineers.

“Initially I thought I would go to medical school and become a doctor, but I remember calling my mom sophomore year in college and saying ‘I’m going to miss my math.’ I realized at that moment that I preferred to be behind the scenes helping patients by making products that will save them..”

Meet Anwesha – recently promoted to Manager, she leads a team of software engineers for our Medication Delivery business.

“I grew up in a small coastal town in India called Bhubaneswar, where we have our own traditions and culture. I think this has helped me grow personally and professionally. Working with a global team at Baxter, my background helps me to be open, appreciate and relate to people from all different places.”

Meet Sam – he has been with Baxter for over 15 years, working as an engineering technologist in Round Lake, IL, US.

“I have a wonderful team. They have been flexible and open to the differences in communication methods and work style necessary for me to excel. If I didn’t have that support, I wouldn’t be where I am now and I wouldn’t have been able to advance within the company. I’m proud to work at Baxter.”

Meet Erika – she has been an engineer in Round Lake, IL, US for over four years, promoted to Senior Principal Engineer in 2019.

“My involvement with National Society of Black Engineers outside of work has afforded me the opportunity to manage Baxter’s external partnership with the organization, exposing us to networking and talent that can help drive diversity and innovation, and providing opportunities for more community engagement and involvement, which I know a lot of my colleagues like.”

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