Principal Risk Engineer

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

As a Principal Risk Engineer, you will collaborate with cross-functional teams 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 standards. A Principal Risk Engineer plans and delivers engineering assignments under the guidance of the Product Risk Management Owner.

What you will be doing:

• Engaged member of the team as a systems risk management engineer of moderate to high complexity devices.
• Coordinates efforts of cross functional teams and/or integrates cross functional inputs to delivery of a project of moderate technical and strategic complexity.
• Analyzes complex designs across engineering disciplines, documenting risks and ensuring risk controls and requirements are met.
• Manages the Design History File (DHF) and ensures the risk management file is up to date and within compliance.
• Ensures cross-functional review, discussion and debate of input; identifies and prepares appropriate stakeholders within functional, program and/or project team to make decisions.
• Ensures inclusion of inputs into product and technical design reviews from all cross functional stakeholders.
• Anticipates technical challenges and risk scenarios and prepares, manages, and implements mitigation strategies to ensure optimal results.
• Understands and contributes to resolution of competing constraints among inter-related functions (e.g. engineering, manufacturing, regulatory, marketing, medical) required to deliver products to market.
• Uses creative thinking and teamwork to resolve conflicts.
• Makes proficient and disciplined critical decisions and systems deliverables (e.g. program milestones, technical design reviews).
• Embraces team and management decisions while also raising issues to appropriate level.
• Works with Project Management to create and manage schedules for systems and sub-systems.
• Designs to meet regulatory requirements as determined by FDA, ISO, and IEC standards.

What you will bring:

• B.S. or M.S in Engineering (Mechanical, Electrical, or Software) with 5+ years of Software, Electrical, or Mechanical Engineering experience.
• Preferred: Minimum of 5 years of relevant experience in medical device industry.
• Preferred: Previous design experience i.e., design inputs and outputs and the design review process.
• Cross-functional team collaboration experience, including technical and non-technical work.
• Success in delivering results on technical challenges including investigative and problem-solving skills
• Has organized and presented technical and project overviews without assistance.

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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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.

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 $104,000 - $143,000 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