Sr Engineer, Systems

Baxter Healthcare; Bengaluru; On-site; INR 1,800,000 - 2,400,000; Full time

Job summary

Baxter Healthcare in Bengaluru (Bangalore) is seeking a Senior Engineer - Systems & Model Based Design to contribute to design and verification of medical devices. You will apply model-based design and MATLAB models with hardware and software teams, supporting cross-functional collaboration to resolve complex issues.

You will work with Verification & Validation teams across divisions, applying design controls and regulatory knowledge to ensure safe, effective products.

Qualifications

• Bachelor's or Master's in Biomedical/Electrical/Software/Computer/Mechanical/Industrial engineering or related field
• Experience in System engineering function of Medical device/Medical Imaging/Image processing
• Experience in Medical Device development, FDA Regulations and MDR
• Exposure to Usability Engineering Process
• Experience with QFD, Pugh Matrix, CTQ, DFR, DFX

Responsibilities

• Identify and define customer needs and requirements early in development with awareness of design trade-offs and regulatory constraints
• Use MATLAB to develop Model Based Design with hardware and software teams to accelerate product development
• Ensure project meets cost, quality and schedule targets throughout the life cycle
• Develop Use Cases based on customer environments and product context
• Manage requirements and decomposition of system-level requirements to modules
• Support verification and validation activities and issue resolution with engineers across disciplines
• Assist Usability Engineering to demonstrate IEC 62366 and FDA guidance compliance
• Contribute to reliability and robustness considerations in design
• Produce detailed technical documentation of designs and verification results
• Support integration tests and ensure module/system development success

Skills

Model Based Design

MATLAB

Systems engineering

Cross-functional teamwork

FDA regulatory knowledge

Design controls

Problem solving

Education

Bachelor's or Master's in Engineering

Tools

MATLAB

Job description

This is whereyour 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.

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