Principal Engineer, Quality

Your role at Baxter

This is where your expertise helps people

You are a problem solver. Complex projects or unexpected challenges are just opportunities to bring your considerable abilities to use. Whether working independently or with a trusted team, you are always ready to tackle a project and work hard to find solutions.

Your talent is needed across a wide variety of industries. As a Principal Engineer, Quality, you have a wide array of career choices but are motivated by the opportunity to work in a company that supports innovation, professional development, and a purposeful mission.

We are a team of inquisitive individuals who embrace a collaborative environment to take on sophisticated challenges that meet the needs of our patients. We often need to change directions and respond to issues to avoid disruptions in our fast‑paced manufacturing environment. Together, we build and maintain a positive work environment.

Our Engineering Team is dedicated to quality. Delivering life‑saving products is about getting them right, and our technical expertise and experience working in a manufacturing environment empower us to meet that challenge.

When you join us, you will work with a team of committed individuals who trust each other to deliver on the tasks  support innovation and out‑of‑the‑box thinking balanced with collaboration across functions and other teams. Our leadership understands the need for continuous education and provides opportunities for further development.

As a Principal Engineer, Quality, you will have the opportunity to lead by example and enjoy mentoring and learning from others. Here, you are trusted to manage your own time and are given opportunities to grow your career as you wish.

Here, you often have the flexibility to work independently. We provide opportunities for you to continue to learn through various training, conferences, certifications, and support for advanced degrees.

• Provide quality assurance support and guidance for product design activities including Design and Development Planning, Design Input, Design Output, Design Review, Design Verification and Validation, Design Transfer, Design Changes.

• Ensure compilation and maintenance of product Design History Files.

• Partner with Sustaining Engineering and Research & Development 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.

• Document traceability of requirements through design output and to design verification and/or design validation.

• Insist on early requirement maturation, early test plan/script development, and design input requirements that are indicative of real world use case environment and customer needs.

• Review intended use validation for non-product software and tools used in the development process.

• Actively participate with design teams on developing product Risk Management Files; ensure risk assessments adequately address safety and efficacy and are compliant to the highest standards.

• Perform DHF audits of other products as an independent reviewer.

• Support external regulatory and customer audits.

• Support nonconformance and CAPA investigations and improvement action plans.

• Collaborate with global Design Assurance team to drive continuous improvement, including development of standard work, aspiring for a world‑class Product Development Process.

• Bachelor’s degree in engineering or related field.

• 5+ years’ experience in medical device or other regulated technical industry (e.g., aerospace, automotive, defense).

• Experience with development of embedded software, and stand‑alone software as a medical device is required.

• Experience with development of mechanical or electronic devices is a plus.

• Experience with manufacturing processes is a plus.

• Strong working knowledge of design controls as required by FDA 21 CFR 820.30, European Medical Device Regulation and ISO 13485 product realization.

• Knowledge of Quality Management Systems beyond design control compliant with FDA 21 CFR 820 and ISO 13485, product safety standards (e.g., IEC and ANSI/AAMI),…