Principal Systems Engineer​/PDO

Principal Systems Engineer

This is where your 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.

The Principal Systems Engineer will serve as a Product Design Owner (PDO) responsible for technical owner for the design, risk and integration of infusion pump systems and/or projects, which combine electro-mechanical hardware, embedded software, and user interface components, as well as the interface with other related EM and/or digital products. This role drives operational excellence and predictable, consistent execution in our products, and design and risk integrity and may serve as Risk Owner on some projects.

The engineer is accountable for product safety, performance, reliability, usability and regulatory compliance, as well as risk. The PDO drives design decisions, manages design control activities, may be accountable for a product risk file, and collaborates across engineering disciplines and cross-functions to deliver robust, reliable, safe and innovative infusion therapy solutions.

What you will be doing:

• Leads interdisciplinary design and development of medical products in compliance with FDA, EU MDR, ISO 13485 and other global regulatory standards to enhance patient outcomes. Accountable for end-to-end system traceability completeness.
• Has final technical decision authority, leads trade-off analysis and makes critical decisions. Ensures technical risks are anticipated and identified, mitigations implemented and aligned with product objectives at all stages of a project. Works in collaboration with Product Risk Owner and may serve as Risk Owner.
• Accountable for and drives overall product requirements, architecture, interfaces and product design realization, ensuring inclusion of inputs from all stakeholders.
• Understands and resolves competing constraints while driving collaboration of the technical team as well as cross-functionally (engineering, manufacturing, regulatory, clinical, commercial, etc) throughout the product lifecycle.
• Accountable for content and robustness of design reviews and program design changes, and compliance with PDLM processes and procedures, including DHF documentation and audit and regulatory submissions technical preparation.
• Fosters a creative, collaborative and innovative environment including focus on innovation and continuous improvement.

What you will bring:

• Must have good working knowledge of regulations and standards affecting medical devices and have experience with products under design control
• Bachelor's degree in engineering (Mechanical, Electrical, Software, or similar) with 5+ years of experience.
• Has led the transfer of at least one project.
• Preferred:
  Minimum of 5 years of relevant experience in medical device manufacturing industry.

Baxter is committed to supporting the needs for flexibility in the workplace. We do so through our flexible workplace policy which includes a required minimum number of days a week onsite. This policy provides the benefits of connecting and collaborating in-person in support of our Mission. The flexible workplace policy is subject to local laws and legal requirements. At its discretion, Baxter may decide to adjust, suspend, or discontinue as business needs change.

We understand compensation is an important factor as you consider the next step in your career. At Baxter, we are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. The estimated base salary for this…