Principal Systems Engineer, Product Design Owner

This is whereyour work makes a difference.

At Baxter we believe every personregardless of who they are or where they are fromdeserves 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 jobyou will find purpose and pride.

At Baxter we are deeply connected by our mission. No matter your role your work makes a positive impact on people around the world.

As a Systems Engineer Product Design Owner (PDO) within Front Line Care R&D you will provide technical leadership for Baxters Exam Diagnostics product portfolio throughout the product lifecycle. You will serve as the technical and design authority for assigned products leading cross-functional decision-making managing product changes and ensuring ongoing compliance quality performance and business continuity. This role requires strong systems thinking risk-based decision making and the ability to influence across a global cross-functional organization.

• Serve as Product Design Owner with responsibility for maintaining and evolving product designs throughout the product lifecycle.
• Provide technical assessments tradeoff analyses and risk evaluations to support product and business decisions.
• Lead cross-functional technical decision-making and influence alignment among engineering quality regulatory manufacturing service and commercial stakeholders.
• Lead design changes technical reviews and risk management activities in accordance with Baxters Quality Management System.
• Drive resolution of complex product quality manufacturing and field-related issues.
• Ensure compliance with FDA ISO IEC and applicable design control requirements.
• Partner with Quality Regulatory Manufacturing Service Supply Chain Marketing and Program Management to achieve product and business objectives.
• Support complaint investigations supplier corrective actions product changes and post-market activities.
• Identify opportunities to improve product performance reliability manufacturability quality and cost.
• Mentor and guide engineering teams through technical problem solving and product lifecycle management.

• Bachelors degree in Systems Biomedical Electrical Mechanical Computer Software Engineering or a related technical field.
• 5 years of experience in product development systems engineering sustaining engineering or product lifecycle management within a regulated industry.
• Demonstrated technical expertise across hardware software and integrated systems.
• Strong understanding of Design Controls Risk Management Verification & Validation and Product Lifecycle Management processes.
• Knowledge of FDA ISO IEC GMP/QSR and applicable regulatory requirements.
• Proven ability to lead through influence and drive cross-functional decision-making.
• Strong analytical problem-solving and communication skills.
• Ability to thrive in a global matrixed organization.

• Experience serving as a Product Design Owner Systems Engineer Lead Systems Designer Product Architect or Technical Lead.
• Experience supporting post-market quality investigations sustaining engineering or manufacturing changes.
• Experience with connected medical devices digital health or software-enabled products.
• Advanced degree or relevant professional certifications preferred.

We understand compensation is an important factor as you consider the next step in your career. At Baxter we are committed to equitable pay for all employees and we strive to be more transparent with our pay practices. The estimated base salary for this position is $112000 to $154000 annually. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than of the anticipated range based upon market data and other factors all of which are subject to change. Individual pay is based on upon location skills and expertise experience and other relevant factors. This position may also be eligible for discretionary bonuses. For questions about this our pay philosophy and available benefits please speak to the recruiter if you decide to apply and are selected for an interview.

Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time.

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US Benefits at Baxter (except for Puerto Rico)

This is where your well-being matters. Baxter offers comprehensive compensation and benefits packages for eligible roles. Our health and well-being benefits include medical and dental coverage that start on day one as well as insurance coverage for basic life accident short-term and long-term disability and business travel accident insurance. Financial and retirement benefits include the Employee Stock Purchase Plan (ESPP) with the ability to purchase company stock at a discount and the 401(k) Retirement Savings Plan (RSP) with options for employee contributions and company matching. We also offer Flexible Spending Accounts educational assistance programs and 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 and paid parental leave. Additional benefits include commuting benefits the Employee Discount Program the Employee Assistance Program (EAP) and childcare benefits. Join us and enjoy the competitive compensation and benefits we offer to our additional information regarding Baxter US Benefits please speak with your recruiter or visit our Benefits site: Benefits Baxter

Equal Employment Opportunity

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race color religion gender national origin age sexual orientation gender identity or expression protected veteran status disability/handicap status or any other legally protected characteristic.

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Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If because of a medical condition or disability you need a reasonable accommodation for any part of the application or interview process please click on the link here and let us know the nature of your request along with your contact information.

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