Principal Engineer, Quality

Aquí es donde salvas y sostienes vidas

En Baxter, estamos profundamente conectados por nuestra misión. No importa tu rol en Baxter, tu trabajo tiene un impacto positivo en la gente alrededor del mundo. Sentirá un propósito en toda la organización, ya que sabemos que nuestro trabajo mejora los resultados para millones de pacientes.

Los productos y terapias de Baxter se encuentran en casi cada hospital del mundo, el clínicas y en los hogares. Por más de 85 años hemos sido pioneros en innovaciones médicas significativas que transforman el cuidado en salud.

Juntos creamos un lugar donde somos felices, exitosos y nos inspiramos mutuamente. Aquí es donde puedes hacer tu mejor trabajo.

Únete a nosotros en la intersección de salvar y sostener vidas-donde tu propósito acelera nuestra misión.

Your Role at Baxter

As a Principal Engineer, Product Quality, you will ensure the establishment and execution of world-class Design Control processes that deliver safe and reliable products, while also enabling speed to market. You will partner with the Sustaining Engineering team in the design maintenance of FDA Class I and Class II medical devices to ensure that design control principles are followed, and that safety & efficacy are demonstrated. At all times throughout the process, you will identify and mitigate risks.

Your Team

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 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 committed individuals who trust each other to deliver on the tasks at hand. We 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.

What You'll Be Doing

• Provide quality assurance support and oversight 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 requirements' 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, striving for a world-class Product Development Process.

What You'll Bring

• Bachelor’s Degree in Engineering.

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

• Experience with development of mechanical or electronic devices is required.

• Experience with manufacturing & software development 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), Human Factors/Usability Engineering, statistical analysis methods, ISO 14971 Risk Management and cybersecurity controls are a plus.