Sr Eng, Design Assurance

Baxter Healthcare; Monterrey; Presencial; MXN 899,000 - 1,259,000; Jornada completa

Descripción de la vacante

A healthcare technology company in Monterrey, Mexico is seeking a Design Assurance Engineer to ensure product quality and compliance in medical device development. The role involves collaborating with R&D and Quality Assurance teams, providing mentorship on product changes, and engaging in risk management activities. Ideal candidates will have 3+ years of experience in regulated industries, a Bachelor's degree in engineering, and strong problem-solving skills. This position offers a chance to make a meaningful impact in healthcare delivery.

Formación

• 3+ years’ experience in medical device or regulated industry required.
• Strong problem-solving and root cause analysis skills needed.
• Proven ability to communicate complex issues clearly.

Responsabilidades

• Provide quality assurance support for product change activities.
• Review test plans, protocols, and reports.
• Ensure documentation traceability and risk management.

Conocimientos

Attention to detail

Interpersonal skills

Educación

Bachelor’s degree in engineering or related field

Descripción del empleo

This is whereyour 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
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Ave. del Teléfono #200|Huinalá en Apodaca|66640 Monterrey, NLE|Mexico