Engineer II, Systems

Zvh; Bengaluru; On-site; INR 1,200,000 - 2,100,000; Full time

Job summary

Baxter is seeking an Engineer II, Product Owner to contribute to design and development from concept to verification and validation. You will apply engineering principles and collaborate with cross-functional teams to address complex technical challenges and deliver high-quality healthcare solutions.

You will define system requirements, lead risk management per ISO 14971, and support regulatory compliance throughout the development lifecycle, while coordinating with software, hardware and

Qualifications

• Bachelor's degree in Mechanical/Electrical/Electronics/Software/CS/Biomedical/Industrial Engineering or related field.
• 3–6 years of Systems Engineering experience with electro‑mechanical development.
• Experience in regulated medical devices with FDA/MDR standards.

Responsibilities

• Define and translate requirements into system specifications and product requirements.
• Lead requirements engineering activities including use case development and traceability.
• Apply ISO 14971 risk management and ensure product safety and regulatory compliance.

Skills

Systems engineering

Cross-functional collaboration

Problem solving

Analytical thinking

Regulatory awareness

Education

Bachelor's degree in Mechanical Engineering or related field

Tools

DOORS

Polarion

Job description

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

The role of Engineer II , Product Owner is to contribute in design and development of a product or solution, from conception to design and verification/validation. You will apply expert technical knowledge and engineering principles in the development of products and solutions. You will collaborate with cross functional team for technical issues, design changes, design reviews, and complex problem resolution.

What You’ll Be Doing

Define and translate customer, business, regulatory, performance, usability, and safety requirements into clear system requirements and product specifications. Lead requirements engineering activities, including use case development, requirements decomposition, traceability, and change management using tools such as DOORS, Polarion, or equivalent platforms. Apply systems engineering principles to balance design trade-offs, identify risks early, and support informed technical decision-making. Execute and support risk management activities in accordance with ISO 14971, ensuring product safety and regulatory compliance throughout the development lifecycle. Partner with cross-functional engineering teams to resolve technical challenges and drive optimal technology solutions. Support Usability Engineering and Human Factors activities, ensuring compliance with IEC 62366 and relevant FDA guidance. Apply reliability and robustness engineering principles to enhance product performance, quality, and customer experience. Develop high-quality technical documentation that effectively communicates system architecture, requirements, design decisions, and development outcomes. Collaborate closely with software, hardware, and systems teams to support successful product integration and development testing. Work with Verification & Validation (V&V) teams to define comprehensive verification strategies and test plans that ensure thorough requirements coverage. Provide technical leadership and expertise to help projects achieve key objectives related to quality, cost, schedule, and regulatory compliance. Contribute to the successful delivery of innovative healthcare solutions by championing best practices in systems engineering, risk management, and product development.

What You’ll Bring

Bachelor's degree in Mechanical Engineering, Electrical Engineering, Electronics Engineering, Software Engineering, Computer Science, Biomedical Engineering, Industrial Engineering, or a related technical discipline. 3-6 years of experience in Systems Engineering, with a strong focus on electro-mechanical product development. Experience supporting the development of complex products within highly regulated industries, preferably medical devices. Working knowledge of FDA regulations, Medical Device Regulation (MDR), and applicable quality and regulatory standards. Experience with requirements management, systems engineering processes, and product lifecycle development. Familiarity with Usability Engineering and Human Factors Engineering methodologies. Understanding of design and development tools and methodologies such as QFD (Quality Function Deployment), Pugh Matrix, CTQ (Critical to Quality), Design for Reliability (DFR), and Design for Excellence (DFX). Knowledge of FDA, ISO, and IEC standards, including design controls, risk management, and product development best practices. Strong analytical and problem-solving skills with the ability to evaluate complex technical challenges and recommend effective solutions. Proven ability to manage multiple priorities and successfully deliver project objectives within quality, cost, and schedule expectations. Excellent communication and interpersonal skills, with a demonstrated ability to collaborate effectively across cross-functional teams.

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.

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally.

Since 1931, we have been at the forefront of innovation by bringing smarter, more personalized care to patients around the world. Now, we’re more determined than ever to make a lasting impact as we are redefining healthcare delivery across the care journey. Our Mission to Save and Sustain Lives motivates us as we create a culture in which each of us can succeed. This is where you belong.