Eng II, Systems C&S Job at Baxter (Bengaluru)

Job Description

This is where new knowledge is discovered. Baxter’s Research and Development teams work cross functionally to innovate, develop and introduce creative solutions for patients needs globally. From Scientists to Engineers, your work creates the products that save and sustain lives.

Job Responsibility

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, C&S assessment early in the development cycle working independently or under the guidance of senior staff
Execute compliance testing as a part of the development team to ensure that the project successfully meets cost, quality and schedule targets throughout the product life cycle
Use tools such as DOORS and excels in the management of requirements and decomposition of system level requirements to modules and their respective compliance requirements
Carry out risk management process in accordance with the EN ISO 14971 throughout product life cycle to ensure compliance and product safety
Excels 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
As Lead integrator for the product proactively look out for integration issues during development tests and ensure module / system development is successful
Lead the effort in complying with IEC 60601-1 and collateral standards to obtain product approvals from external safety test labs and notified bodies (DQS, UL, ETL, TUV, LNE, etc.)
Excels in obtaining and maintaining 3rd party Product Certifications, Type approvals and technical files
Actively engage with verification and validation engineers to aid in the development of verification scripts with good test coverage
Provides support during Notified Body audits & follow-ups
Excel in the creation and maintenance of technical files to the MDD and STED to MDR for CE mark
Excels in providing support in the creation of Declaration of Conformance for applicable products
Support in the creation and maintenance of Declaration of Conformity
Communicates and educates R&D teams on codes & standards requirements, and their implementation
Collaborates with QA/RA to register products in different geographical regions
Documents status and results accurately and succinctly, and with purpose

Requirements

Bachelor's Degree in Mechanical engineering, Electrical Engineering, Electronics Engineering, Software Engineering, Computer Science, Bio-Medical, Industrial Engineering or related field
3 to 8 yrs of experience, mainly in Codes and Standards, testing & System engineering function of Electro-Mechanical System Design
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
Excellence in Medical Devices safety (IEC 60601-1 and collaterals for medical devices like cardiology, patient monitoring and respiratory therapies), FDA Regulations or other applicable regulatory requirements
Excellence in Medical Device software life cycle processes (IEC 62304), EMI/ EMC requirements, REACH, ROHS and Biocompatibility
Demonstrated experience in accomplishing objectives
Able to deliver on multiple projects simultaneously
Self-motivated with good interpersonal skills

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer

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Eng II, Systems C&S

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