Principal Systems Engineer, Risk Management (Hybrid)

This is where you save and sustain lives

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.

Join us at the intersection of saving and sustaining lives- where your purpose accelerates our mission.

Your Role at Baxter

This is where you save and sustain lives.

The research we do and the products we develop improve outcomes for patients around the world. As a Principal Engineer at Baxter, your work contributes directly to making a significant impact on others. It's challenging work-and you're not on your own. Our teams collaborate cross-functionally and lead by influence. Whether guiding a team through a project or managing direct reports, our research and development team is responsible for influencing others to achieve results. Our colleagues within our R&D organization desire to work on products that make a meaningful difference in others' lives. We are motivated by the power of teamwork and are natural leaders who are skilled at influencing others.

Your Team

As the Principal Systems Engineer for Risk Management, you will contribute to design concepts and research methodologies that meet current and future customer & business needs for a life-saving medical device. As a Principal Risk Engineer, you will collaborate with cross-functional stakeholders to design complex medical devices that meet customer needs and regulatory standards. This role includes application of ISO 14971 standard risk management principles, methods, and techniques to ensure products meet medical device design control best practices. You will also be responsible for the planning and execution of engineering assignments under the guidance of the Product Risk Management Owner.

What you'll be doing:

• Embrace accountability for smaller deliverables that are a part of a larger project. Leads small sub-projects, as necessary, to accomplish objectives within area/role of responsibility.
• Analyze complex designs across engineering disciplines, documenting risks and ensuring risk controls and requirements are met.
• Perform Risk Assessments for issues occurring during new product development.
• Develop change control assessments, detailed impact plans, generating or reviewing risk documentation updates.
• Analyze data sources such as device utilization logs, medical literature and complaint data to estimate risk.
• Understand and contribute to resolution of competing constraints among inter-related functions (e.g., engineering, manufacturing, regulatory, marketing, medical) required to deliver products to market.
• Perform work with awareness of FDA, ISO and IEC design control procedures, regulations and standards within area of responsibility.

What you'll bring:

• BS in Engineering and 5+ years related experience.
• Prior experience with product development lifecycle management (exploratory, new product development, or sustaining product support) including requirements management, risk management, V&V, and/or change management. Medical Device experience with Infusion Pumps and Syringe Pumps is a plus.
• Effective written and verbal communication skills.
• Experience with other development and systems engineering tools preferred (e.g. Minitab, DOORS, ALM, etc.)

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 $68,000 to $156,000 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.

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The successful candidate for this job may be required to verify that he or she has been vaccinated against COVID-19, subject to reasonable accommodations for individuals with medical conditions or religious beliefs that prevent vaccination, and in accordance with applicable law.

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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Pay Transparency Policy

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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