Baxter

Healthcare

ProductDesignOwner

$128–128k Round Lake, Illinois, United States FULL TIME
Market Sentiment
HIGH DEMAND

Neural analysis suggests this role is
optimal for Senior candidates.

The Brief

“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.

Healthcare
Problems you'll solve

Trade-off analysis; Risk assessment; Resolving constraints

Eligibility Requirements

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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