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Principal Quality Engineer

Req #: JR - 048661 Location Saint Paul, Minnesota, United States Job Category: Engineering Date Posted: 09/02/2021

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.

  • Support for Parents

  • Continuing Education/
    Professional Development

  • Employee Health &
    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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Principal Quality Engineer

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. 

Summary

Provide Quality Leadership and support to the value stream product teams for biological and/or mechanical medical devices. Ensure proper product design and manufacturing process design and execution for such devices.

Essential Duties and Responsibilities

  • Participate on product development teams to improve current product and transfer of the design to manufacturing. Participate in risk management activities (quality planning, product and process risk assessment and risk management), review and approval of process and product validation protocols and reports, review component qualifications, and test method development/validation.

  • Lead site initiatives to implement validation programs, inspection programs, regulatory compliance programs.

  • Set statistically valid inspection requirements, including identifying test methods and sampling plans and assist with designing inspection fixtures. Assure measurement systems are capable using MSA, when applicable.

  • Partner with manufacturing on quality related process improvement projects, lean manufacturing projects, and equipment qualification/validation, through review and approval of protocols and reports.

  • Investigate, analyze, review and report on Product Complaints (Field Events).

  • Participate on and lead process improvement teams to implement quality improvement activities using Lean, and Six-Sigma methods.

  • Be the site lead to implement systems and processes for global alignment Lead or participate in Corrective and Preventive Actions (CAPA).

  • Ensure alignment of site processes to business-wide processes.

  • Manages coaching, training and development of subordinates.

Qualifications

  • Job experience or advanced training and demonstrated proficiency in total quality management, statistical methods, quality tools, root cause analysis / resolution, risk analysis, SPC, MSA, and design of experiments.

  • Experience in new product development, materials science, and biocompatibility.

  • Excellent oral and written communication skills.

  • Strong problem solving, technical writing, organizational, leadership, and interpersonal skills.

  • Successful track record of leading large or complex projects and diverse teams.

  • Working knowledge of FDA Quality System Regulations, ISO-13485, and ISO-14971.

  • Proficient MS Office skills including MS-Project and Visio.

  • Must have the ability to read/interpret design prints.

Education/Experience

Required

  • B.S. degree in Engineering, or related scientific discipline. ASQ CQE certification required if 4 year degree is not in engineering.

  • 6-8 years of experience in quality and/or product development.

Preferred:

  • Advanced technical degree preferred.

  • ASQ Certification in Quality Engineering and/or Auditing is highly desirable.

  • Prior supervisory experience.

  • Microbiology and sterilization validation experience highly desirable.

  • Experience with biological products and/ or chemical processing highly desirable.

  • Previous Quality Auditing experience is desirable

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.

EEO is the Law 
EEO is the law - Poster Supplement
Pay Transparency Policy

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.

048661

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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