Principal Engineer, Product Design Owner

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. 

Your Role at Baxter

This is where your work saves lives

The research we do and the products we develop improve outcomes for patients around the world. As a Product Design Owner at Baxter, your work contributes directly to making a significant impact on others. It is challenging work—and you're not on your own. Our teams collaborate multi-functionally and lead by influence. Whether guiding a team through a project or managing direct reports, our research and development team is responsible for influencing others to achieve results.

Our colleagues within our R&D organization desire to work on products that make a meaningful difference in others’ lives. We are driven not by what will be easy, but by what will transform global healthcare for generations to come. We are motivated by the power of teamwork and are natural leaders who are skilled at influencing others.
 

Your Team

While everyone at Baxter has a shared passion for our mission, the R&D teams play a meaningful role in our ability to save and sustain lives. Scientists and engineers in R&D work together to develop, test, and launch products that enhance patient care.

We encourage teamwork and collaboration and prioritize building relationships with each other! It's easy to do because we all share common traits of reliability, ethical, and caring. We lean on our colleagues for their expertise and hold each other accountable.
 

What you'll be doing

Product Design Owner I (PDO I) is responsible for the management of the design of the Baxter Front Line Care Connected Monitoring products throughout the on-market product lifecycle.

Knowledgeable in Product Design and Development and Quality System, Lifecycle Management Processes, the intended and actual use of the products, and has technical expertise associated with assigned product and/or domain. Open to seek guidance wherever needed to perform their duties.

• As key team member of the Connected Monitoring Core Team, the PDO is responsible for providing the technical assessment inputs & associated risks in enabling the Business Priority decision for the product and/or design change along with commercial and program inputs.
• Has authority and accountability to maintain and/or update the product design.
• Ensures compliance, quality and continuity of products in the market.
• As part of the on-market support multi-functional team, PDO works on the technical challenges and risk scenarios and prepares, leads and implements mitigations to ensure optimal results in conjunction with the Sustaining Engineering organization.
• Ensures Design Reviews and technical reviews are conducted as required by the quality system.
• Approves, controls and owns Design History File (DHF) elements (may or may not be authoring), Product and Process Changes, including managing the Risk Management Assessment in conjunction with the Product Risk Management Owner.
• Responsible to drive continuous alignment to FDA, ISO, and IEC design control procedures, regulations and standards ensuring the product compliance and regulatory changes/new geographic expansion needs.
• Uses current product knowledge to facilitate change control when required for product support such as SNC, SCAR and complaint investigation. Or updates to the DHF and user documentation.
   

What you'll bring

• Bachelors Degree in Computer Science, Mechanical, Electrical, Biomedical Engineering or other relevant subject areas with 5+ years of proven experience.
• 5+ years of validated experience in product lifecycle management (sustaining) or other related product development expertise in a regulated industry.
• Knowledgeable in Product Design/Development, Quality System, Lifecycle Management Processes, the intended and actual use of the products, and has technical expertise associated with assigned product and/or domain.
• Proven application of knowledge in Hardware, Software, and System engineering.
• Have the knowledge of the regulatory environment for