Baxter
Healthcare
ProductDesignOwner
Neural analysis suggests this role is
optimal for Senior candidates.
“Product Design Owner at Baxter. Skills: Product Design Owner, Systems engineering, Medical device design. Lead design and development of medical products. Ensure end-to-end system traceability completeness”
Industry & Context.
Trade-off analysis; Risk assessment; Resolving constraints
Authorized to work in U.S., Minimum days onsite per week
What They're Looking For.
Must Have
Bachelor’s degree in engineering, 8+ years of experience, Experience with products under design control, Working knowledge of regulations and standards affecting medical devices
Nice to Have
Minimum of 5 years of relevant experience in medical device manufacturing industry
What You'll Do.
Lead design and development of medical products
Ensure end-to-end system traceability completeness
Make critical technical decisions
Anticipate and identify technical risks
Implement mitigations
Ensure product safety
Ensure product performance
Ensure product compliance
Ensure product usability
Ensure product reliability
Ensure product quality
Drive product requirements
Drive product architecture
Drive product interfaces
Drive product design realization
Resolve competing constraints
Ensure product manufacturability
Ensure product serviceability
Ensure robustness of design reviews
Ensure compliance with PDLM processes
Prepare regulatory submissions
Direct technical team
Mentor technical team
Complete projects on schedule
Ensure deliverable quality
Develop technical schedule
How You'll Work.
Team & Collaboration
Interdisciplinary design; Cross-functional collaboration; Engineering disciplines; Cross-functional teams; Technical team; Cross-functionally
Process & Methodology
Schedule management
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** 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. **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 techni
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