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Agent guide: [/agents.md](https://www.wearedevelopers.com/agents.md). --- # Product Design Owner - **Company:** Baxter - **Location:** Round Lake, IL, United States (Remote available) - **Experience:** Expert - **Salary:** $128,000.0 - $176,000.0 - **Contract:** Permanent contract - **Skills:** Systems Engineering, Embedded Software, Human-Computer Interaction, Program Design Languages, Systems Architecture - **Published:** May 17, 2026 - **Apply:** https://www.careerjet.com/jobad/us271997a5c452150bfb69b472071dcdc6 ## About the Role 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 8+ years of experience. Preferred: Minimum of 5 years of relevant experience in medical device manufacturing industry. ## Description 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 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 close collaboration with Product Risk Owner. * 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., 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. ## Related Videos - [Model Based Systems Engineering in an Agile Product Development Process](https://www.wearedevelopers.com/videos/68-model-based-systems-engineering-in-an-agile-product-development-process) - [Breaking the Hardware Mindset: Overcoming Barriers to System-Level Innovation](https://www.wearedevelopers.com/videos/1635-breaking-the-hardware-mindset-overcoming-barriers-to-system-level-innovation) - [From Bedside Beeps to Interoperable Bytes – Getting your medical devices ready to talk the IEEE 11073 language](https://www.wearedevelopers.com/videos/771-from-bedside-beeps-to-interoperable-bytes-getting-your-medical-devices-ready-to-talk-the-ieee-11073-language) - [The QUEST for Better Software](https://www.wearedevelopers.com/videos/721-the-quest-for-better-software) - [Building a hypercar from scratch](https://www.wearedevelopers.com/videos/607-building-a-hypercar-from-scratch) - [UX is a fullstack job!](https://www.wearedevelopers.com/videos/1020-ux-is-a-fullstack-job) ## Related Articles - [How Developers Can Focus on Maintaining Satisfaction With Accessibility](https://www.wearedevelopers.com/magazine/109-how-developers-can-focus-on-maintaining-satisfaction-with-accessibility) - [Now is the time for industrialized software development](https://www.wearedevelopers.com/magazine/601-now-is-the-time-for-industrialized-software-development) - [Fully Remote Software Engineer Jobs](https://www.wearedevelopers.com/magazine/447-fully-remote-software-engineer-jobs) - [What is Software Engineering?](https://www.wearedevelopers.com/magazine/289-what-is-software-engineering) - [How software is steering vehicle technology](https://www.wearedevelopers.com/magazine/515-how-software-is-steering-vehicle-technology) - [What is product discovery and why do developers need it?](https://www.wearedevelopers.com/magazine/517-what-is-product-discovery-and-why-do-developers-need-it)