Sr. Engineer - Product Quality/Design Assurance

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 Sr. Engineer - Product Quality/Design Assurance, will work as an embedded partner member in R&D project teams in Sustaining Engineering in the maintenance of Design History Files for various medical devices at the Monterrey, Mexico.

The Product Quality/Design Assurance engineer on project has joint responsibility for the design and development plan with the overall project leader and helps project teams deliver sophisticated medical device projects on time with the highest quality and product safety. The engineer will ensure that design controls requirements are adhered to, and that safety and efficacy are proven.  At all times throughout the process, the engineer will identify and mitigate risks and collaborate closely with global groups in R&D, Quality Assurance and Regulatory Affairs functions.

As a Sr. Engineer - Product Quality/Design Assurance, the successful candidate will also ensure the establishment and execution of world-class Design Controls processes that deliver safe and reliable products, while also enabling speed to market.  This position will simultaneously be responsible for participating in various Design Assurance improvement initiatives to improve the overall quality of new product designs and the company’s regulatory compliance profile per FDA 21CFR820.30, European Medical Device Regulation and other regulations.

What you will be doing:

• Provide quality assurance support and guidance for product change activities including: Design and Development Planning, Design Input, Design Output, Design Review, Design Verification and Validation, Design Transfer
• Partner with R&D and Sustaining Engineering to ensure design reviews are thorough and robust
• Review and approve Design Verification and Validation test plans, protocols and reports; guide the use of robust statistical techniques
• Ensure documentation of traceability of requirements through design output and to design verification and/or design validation
• Actively participate with change teams on developing product Risk Management Files; ensure risk assessments adequately address safety and efficacy and are compliant to the highest standards
• Review/approve product and process change control documentation and specifications
• Work closely with Operations to identify and resolve production and quality system deficiencies
• Other duties may be assigned.
• Opportunity to work in a hybrid work-model with work from home and on site.

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 preferred.
• Strong, demonstrated ability to interact closely on technical terms with R&D personnel is required
• Detail oriented with strong organizational and record keeping skills is required.

Education and/or Experience:

• Bachelor’s Degree in engineering or related field is required
• Strong problem solving and root cause analysis skills is preferred
• 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 meaningful discussions and maintain enthusiasm for efforts is required
• Proven ability in being proactive and timely in execution of assigned tasks is required
• Ability to be flexible and adaptable to changing priorities is required

Baxter is committed to supporting the needs for flexibility in the workplace. We do so through our flexible workplace policy which includes a minimum of 3 days a week onsite. This policy provides the benefits of connecting and collaborating in-person in support of our Mission.

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.

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