Baxter
Healthcare
ProductOwner
Neural analysis suggests this role is
optimal for Mid+ candidates.
“Product Owner at Baxter. Skills: Product design, Systems engineering, Risk engineering, Medical device industry. Maintain and/or update the product design. Provide technical assessment inputs & associated risks”
Industry & Context.
Risk assessment; Conflict resolution
Relocation Assistance Provided, Authorized to work for any employer in the U.S.
What They're Looking For.
Must Have
Bachelors Degree in Computer Science, Mechanical, Electrical, Biomedical Engineering or other relevant subject areas, 5+ years of proven experience, 5+ years in product design, systems and risk engineering within the medical device industry, Proven track record in software-enabled product development, especially involving connectivity (Bluetooth, Wi-Fi), Proven application of knowledge in Hardware, Software, and System engineering, Knowledge of the regulatory environment for design, development and manufacturing, Knowledge of manufacturing practices and improvements, Ability to work collaboratively as part of a global multi-functional team
Nice to Have
Familiarity with IEC, ISO, FDA and other regulatory standards and GMP/QSR environment
What You'll Do.
Maintain and/or update the product design
Provide technical assessment inputs & associated risks
and continuity of products
Consider input from external/internal stakeholders
Drive conflicts to resolution
Drive team to agree to a unified decision
Consider inputs into implementable design solutions
Work on technical challenges and risk scenarios
lead & execute mitigations
Ensure Design Reviews and technical reviews are conducted
and own Design History File (DHF)
Manage the Risk Management Assessment
Drive continuous adherence to FDA
Ensure product compliance and regulatory changes/new geographic expansion
Utilize current product knowledge to facilitate change control
Approve the impact assessment of the change and
How You'll Work.
Team & Collaboration
Connected Monitoring Core Team; Global multi-functional team
Full Job Description
**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. **Your role at Baxter** We’re seeking a strategic and technically skilled Product Design Owner with experience, knowledge and background in Software System and Risk Engineering. This role is central to maintaining advanced connected monitoring devices that integrate real-time patient monitoring, embedded software, and hospital EMR systems, delivering seamless and secure data flow across care settings. As a PDO with software and systems expertise, you’ll bring technical insight into system architecture of hospital integration solutions utilizing your knowledge of connectivity protocols. You will be responsible for ensuring our solutions are robust, scalable, and compliant with healthcare standards. You will be responsible for the management of the design of the Baxter Front Line Care Connected Monitoring products throughout the on-market product lifecycle. The PDO is accountable for the product DHF (Design History File), DMR (Device Master Record)/Master Production and Control Record (MPCR) and Risk Management documentation, or similar product design governance documents for a particular product. As a PDO at Baxter, you will further its mission to empower clinicians and health systems with the tools to m
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