Sr. Principal Engineer, V&V (Hybrid)

Vantive : A New Company Built On Our Legacy

Baxter is on a journey to separate our $5B Kidney Care segment into a standalone company. Vantive* will build on our nearly 70-year legacy in acute therapies and home and in-center dialysis to provide best-in-class care to the people we serve.

We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us.

At Vantive, you will become part of a community of people who are focused, courageous and don’t settle for the mediocre.

Each of us are driven to help improve patients’ lives worldwide. Join us as we revolutionize kidney care and other vital organ support.

Completion of the proposed separation of Kidney Care from Baxter into a standalone company (to be named Vantive) remains subject to the satisfaction of customary conditions.

Your Role

Leading the verification and validation of complex electromechanical medical devices. Strategizes, Plans, executes and functionally directs important engineering assignments.

Having independent responsibility of understanding the product requirements & developing / updating the test strategy, test protocols & procedures for the new and / or existing products at Therapy and System level.

It includes verification and validation, environmental, performance, reliability and safety / regulatory related tests and executing the same, documenting the reports.

What You'll be doing

• Responsible for leading verification and validation of complex Systems involving the end-to-end Therapy.
• Responsible for understanding the user needs, product requirements & developing / updating the test protocols & procedures for the new and / or existing products at Therapy, System level and Sub system level.
• Responsible for Test Planning, Test Design and Test Strategy development for a large scale program or several smaller projects.
• Thorough understanding and drives application of phases of product development / life cycle management for areas of responsibility.

Has an understanding of clinical and user needs and is able to apply to product realization

• Provide support for clinical studies
• Lead efforts to co-ordinate with design & development team to start the testing early in the design cycle to ensure the requirements testability, design traceability & test coverage.

Identify issues early to fix them.

• Identifying the root cause and drives action to prevent such issues to recur in future. Proposes and drives solutions to complex technical problems.
• Lead efforts in developing and managing processes and tools required to support the verification and validation activities, including test method validation, management of calibrated equipment and validation of Analytical Instruments.
• Clear understanding and proven experience on basic requirements of unit, integration and system level verification and validation requirements.
• Performs servicing / upgrading of electromechanical test devices
• Ensures good documentation practices are followed in the V&V process.
• Participate in V&V process continuous improvement activities.
• Participates and supports in design reviews.
• Independently plans, schedules and leads cross-functional team in detailed phases of the engineering work in a project.
• May supervise one or more engineers or technicians.
• Adheres to Baxter Quality Management system and support audits and external inspections as applicable. Identify and report any quality or compliance issues during verification & validation activities.
• Drives adherence to FDA, ISO and IEC design control procedures, regulations, and standards within area of responsibility.

Ensures product testing is compliant with internal procedures. Coordinates testing activities with external labs (Sound, ISTA, EMI-EMC).

What you'll bring

• 8 to 12 yrs of experience in Verification and Validation testing (Software, Hardware and System, Preferred : Fluid Management System, Water Systems).
• Relevant technical testing / reliability experience in electro-mechanical, electrical, or software testing.
• Understanding of hardware and software product design methodologies and test practices.
• Good & clear communication
• Critical thinking and ability to apply systems and therapy knowledge to ensure the safety and quality of the product
• Any test automation experience / expertise and / or product validation will be a plus

Baxter is committed to supporting the needs for flexibility in the workplace. We do so through our flexible workplace policy which includes a minimum of 3 days a week onsite.

This policy provides the benefits of connecting and collaborating in-person in support of our Mission.

LI-ASR2