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Product Design Owner

https://www.baxter.com/ Logo

Baxter

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Location:
United States , Round Lake

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Contract Type:
Employment contract

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Salary:

128000.00 - 176000.00 USD / Year

Job Description:

Being an Engineer at Baxter means you play a critical role in helping us achieve our mission to save and sustain lives. From innovative product design through to production and patient delivery, our Engineers are key to delivering results for our customers and patients worldwide. 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 Senior Principal Systems Engineer will serve as a Product Design Owner (PDO), a technical owner for the design 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. The PDO drives operational excellence and predictable, consistent execution in our products, and design integrity. The PDO is accountable for product safety, performance, reliability, usability and regulatory compliance, and is the final decision authority on system architecture, requirements, interfaces and technical risks and trade-offs, and system behavior. The PDO drives design decisions, manages design control activities, and collaborates across engineering disciplines and cross-functions to deliver robust, reliable, safe and innovative infusion therapy solutions.

Job Responsibility:

  • 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
  • Accountable for overall product safety, performance, compliance, usability, reliability and quality in the delivered product
  • 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
  • Ensures product manufacturability and serviceability
  • 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
  • Directs and mentors the technical team to complete projects on schedule, ensuring budget goals are met, and all deliverables are of expected quality
  • Accountable for development of technical portion of schedule in conjunction with PMO
  • Fosters a creative, collaborative and innovative environment including focus on innovation and continuous improvement

Requirements:

  • Bachelor's degree in engineering (Mechanical, Electrical, Software, or similar) with 8+ years of experience
  • Has led the transfer of at least one project
  • Must have good working knowledge of regulations and standards affecting medical devices and have experience with products under design control

Nice to have:

Minimum of 5 years of relevant experience in medical device manufacturing industry

What we offer:
  • Support for Parents
  • Continuing Education/ Professional Development
  • Employee Heath & Well-Being Benefits
  • Paid Time Off
  • 2 Days a Year to Volunteer
  • medical and dental coverage that start on day one
  • insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
  • Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount
  • 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching
  • Flexible Spending Accounts
  • educational assistance programs
  • time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service
  • family and medical leaves of absence
  • paid parental leave
  • commuting benefits
  • Employee Discount Program
  • Employee Assistance Program (EAP)
  • childcare benefits

Additional Information:

Job Posted:
May 16, 2026

Employment Type:
Fulltime
Work Type:
On-site work
Job Link Share:

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