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Sr Eng, Design Assurance

Req # JR - 190009 Location Monterrey, Nuevo León, México Job Category Quality Date posted 12/15/2025
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Overview

This is where you make a difference in our patients’ safety. As a member of the Baxter Quality team, you will play an essential part in our mission of saving and sustaining lives. Quality is important throughout the entire product lifecycle and works collaboratively with all areas of the organization. Because Quality touches everything Baxter does, a role in Quality provides many opportunities for growth, learning and a successful career that has a daily impact on people’s lives.

  • Support for Parents

  • Continuing Education/ Professional Development

  • Employee Heath & Well-Being Benefits

  • Paid Time Off

  • 2 Days a Year to Volunteer

Success Profile

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

  • Detail Oriented
  • Continuous Learner
  • Courageous
  • Collaborative
  • Critical Thinker
  • Influential

Sr Eng, Design Assurance

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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. 

Your role at Baxter:

You as Design Assurance Engineer will work as an embedded partner within R&D Sustaining Engineering teams, handling Build History Files for medical devices in Monterrey, Mexico. This role ensures product quality, design control compliance, and risk mitigation throughout the development process, while collaborating closely with global teams in R&D, Quality Assurance, and Regulatory Affairs.

You will drive outstanding design control processes to deliver safe, reliable products quickly to market and participate in initiatives to enhance design assurance and regulatory compliance in accordance with FDA 21CFR820.30, European Medical Device Regulation, and other standards.

What you will be doing:

  • We provide quality assurance support and mentorship for product change activities including: Planning for Build and Development, Compose Input, Compose Output, Compose Review, Compose Verification and Validation, Compose Transfer. Partner with R&D and Sustaining Engineering to ensure develop reviews are detailed and robust
  • We review and approve test plans, protocols, and reports related to Build Inspection and Confirmation; guide the use of robust statistical techniques
  • We ensure documentation of traceability of requirements through design output and to design verification and/or design validation
  • We actively participate with change teams on developing product Risk Management Files; ensure risk assessments adequately address product safety and efficiency and are compliant to the highest standards
  • We review/approve product and process change control documentation and specifications and work closely with Operations to identify and resolve production and quality system deficiencies

What you will bring:

  • 3+ years’ experience in medical device or other regulated technical industry (e.g., aerospace, automotive, defense) in a design/development role or in a role closely connected to design/development is helpful.
  • Strong, proven track record to interact closely on technical terms with R&D personnel is required and detail oriented with strong interpersonal and record keeping skills is required.

Education and/or Experience:

  • Bachelor’s degree in engineering or related field, or equivalent experience, is required
  • Strong problem solving and root cause analysis skills is helpful
  • Strong written and oral communications skills using English language is required; ability to describe sophisticated issues succinctly and clearly in meaningful ways is required. Ability to engage different functions in significant discussions and maintain passion for efforts is required
  • Proven track record in being proactive and timely in completing responsibilities is required. Ability to be flexible and adaptable to changing priorities is required

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.

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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Address

Explore this location Ave. del Teléfono #200
Huinalá en Apodaca
66640 Monterrey, NLE
Mexico Explore This Location

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 Christelle, Senior Quality Manager in Malta

“I was an Engineering Graduate with a Master's in Business Administration, and was more inclined toward working with people than with machines. When I came across an opportunity to work with Baxter as a Quality Engineer, it was the perfect combination: a manufacturing environment and a role that required me to collaborate with multiple teams daily. Baxter's mission of saving and sustaining lives gives me all the purpose and fulfilment I need.”

Meet Lorena, Senior QA Associate in London, UK

“I am registered pharmacist in the UK with experience with drug products and final product release. I am very dedicated to my work and accurate in details to ensure correct assessment is provided to our customers to ensure patients' safety.”

Meet Gary, Quality Research Manager in Singapore

“I have always enjoyed working at Baxter and I find here to be a great place to work! Management truly cares for you, and invests time and resources to support your career goals and aspirations. My current role provides me the opportunity to work with culturally diverse teams, bringing different talents together, learning from one another and working toward a common goal and mission.”

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