Sr Engineer, Systems,

Baxter International Inc.; Bengaluru; On-site; INR 1,200,000 - 2,600,000; Full time

Job summary

Baxter International Inc. in Bengaluru is seeking a Senior Engineer - Systems & Model Based Design to contribute to product development from conception through verification and validation.

You will apply expert MATLAB MB design, collaborate with hardware and software teams, and drive design reviews, risk management, and regulatory compliance including FDA MDR. This role reports to the Manager - Systems, Verification & Validation within Patient Support Systems and Global Surgical Solutions

Qualifications

• Bachelor's degree with 6+ years or master's with 3+ years in relevant engineering fields.
• Experience in system engineering for Medical devices, Medical Imaging or Image processing; hands-on MATLAB model development.
• Experience with Medical Device development, FDA Regulations and MDR.
• Exposure to Usability Engineering Process.
• Experience with QFD, Pugh Matrix, CTQ, DFR, Design for X/Excellence.
• Strong interpersonal skills and ability to work in cross-functional teams.
• Knowledge of FDA, ISO and IEC design control procedures and standards.
• Proven ability to deliver on multiple projects concurrently.
• Self-motivated with good interpersonal skills.

Responsibilities

• Identify and translate customer needs and regulatory constraints into requirements early in the cycle.
• Use MATLAB to develop Model Based Design alongside hardware and software teams.
• Ensure projects meet cost, quality and schedule targets throughout life cycle.
• Develop Use Cases based on customer environments and requirements.
• Manage system requirements and traceability using standard tools.
• Execute risk management per EN ISO 14971 across the product life cycle.
• Facilitate issue resolution with optimal technology solutions.
• Support Usability Engineering to meet IEC 62366 and FDA guidance.
• Apply reliability and robustness concepts in design development.
• Create detailed technical documentation for designs.
• Assist integration and testing across modules and systems.
• Collaborate with software/hardware engineers to support design development.
• Coordinate verification and validation test planning with adequate coverage.

Skills

System engineering

Medical device dev

FDA regulations

Usability engineering

DFX/DFR

QFD

Team collaboration

Education

Bachelor’s degree in Biomedical/Electrical/Electronics/Software/CS/Mechanical/Industrial Engineering or related

Master’s degree in engineering

Tools

MATLAB

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.

Job Summary

The role of Senior Engineer - Systems & Model Based Design 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 help accelerate the design and development cycle by employing model-based design principles and developing MATLAB models working together with the hardware and software teams. You will collaborate with a cross-functional team for technical issues, design changes, design reviews, and complex problem resolution.

This position is based out of Bangalore and reporting to the Manager - Systems, Verification & Validation for Patient Support Systems and Global Surgical Solutions divisions. You will need to work collaboratively with cross functions Research & Development teams.

What You’ll Be Doing

• Identify and define internal and external customer needs, functions, performance, usability and safety requirement for product or solution with thorough knowledge and understanding constraints - Business and Regulatory, Design trade-offs and Risk assessment early in the development cycle working independently or under the guidance
• Use MATLAB to develop Model Based Design working together with hardware and software teams and help accelerate product development cycle.
• Provide your technical expertise to ensure that the project successfully meets cost, quality and schedule targets throughout the product life cycle.
• Excels in the development of Use Case for product or solution based on intimate knowledge of customers and their environments.
• Use industry standard tools and excel spreadsheets in the management of requirements and decomposition of system level requirements to modules.
• Carry out risk management process in accordance with the EN ISO 14971 throughout product life cycle to ensure compliance and product safety.
• Identify development issues and facilitates in the resolution using optimal technology solutions.
• Supports in the Usability Engineering activities to ensure the application of human factor in the development of products or solutions to demonstrate compliance to IEC 62366 and FDA guidance.
• Knowledge in the application of principles of Reliability and Robustness in the development of products or solution.
• Completes detailed, high-quality technical documentation to capture and communicate designs.
• Support integration issues during development tests and ensure module / system development is successful.
• Actively collaborate with software and hardware engineers to aid in the design development.
• Actively engage with verification and validation engineers to aid in the development of verification test plans with good test coverage.

What You’ll Bring

• Bachelor's Degree with 6+ years or master’s with 3+years’ experience in Bio-medical engineering, Electrical Engineering, Electronics Engineering, Software Engineering, Computer Science, Mechanical Engineering, Industrial Engineering or related field
• Experience in System engineering function of Medical device/ Medical Imaging / Image processing, with hands on experience developing MATLAB system models.
• Experience in Medical Device development, FDA Regulations and MDR.
• Exposure to Usability Engineering Process
• Experience in Quality Function Deployment (QFD), Pugh Matrix, Critical to Quality (CTQ), Design for Reliability (DFR), Design for Excellence / Design for X (DFX)
• Strong interpersonal skills with the ability to collaborate with others in a team environment
• Understanding of and adherence to FDA, ISO and IEC design control procedures, regulations and standards.
• Demonstrated experience in accomplishing objectives. Able to deliver on multiple projects simultaneously
• Self-motivated with good interpersonal skills

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. 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.

Recruitment Fraud Notice

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