Principal Engineer - Systems Engineering

For us, working at Baxter is not just a job—it's a calling. Our mission to save and sustain lives unites us.

We are driven not by what will be easy, but what will transform global healthcare for generations to come. Together, we create a place where we are happy, successful and inspire each other as we pursue rewarding careers.

We're grateful you're interested in continuing your career journey with Baxter. This is where your purpose accelerates our mission and make a positive impact on millions of people around the world. 

JOB SUMMARY: 

A Systems engineering professional with experience in Systems areas like Product Requirements, management, Traceability, DHF structure & maintenance, Product Risk management, System integration, and Verification & Validation of medical devices. This position own & perform relevant Systems activities for a family of products for both PSS & GSS.

The role of Principal Engineer – Systems& MBD 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 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, Patient Support Systems and Global Surgical Solutions divisions.

Essential Duties and Responsibilities: 

·      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 of senior staff. 

·      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. 

·      Involved from new product development to post market surveillance at various stages of product lifecycle.

·      Primary point of contact for R&D for PMO & cross-functional team for integration, execution, project deliverables, budget & resource needs.

Your Team: 

This position will be reporting to the Manager – Systems, Patient Support Systems and Global Surgical Solutions divisions. This position does not have any direct reports. You will need to work collaboratively with R&D and cross functions.   

Your Location: 

The role is in Baxter R&D facility in Bangalore India.   

What You'll Bring: 

·      Bachelor's Degree with 12+ years or Masters with 8+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 QFD, Pugh Matrix, CTQ, DFR, 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

·      Able to deliver on multiple projects simultaneously 

·      Ability to identify compliance risks and escalate, when necessary,

·      Excellent verbal and written English communication skills, suitable for multi-location working relationships,

·      Demonstrated teamwork and collaboration skills,

·      Aptitude for Mindfulness and attention to detail,