Senior Engineer, Systems C&S

Baxter; Bengaluru; On-site; INR 700,000 - 1,200,000; Full time

Job summary

Baxter in Bengaluru, India seeks an Engineer II to contribute to the design and development of medical devices from concept through verification and validation, applying engineering principles and regulatory standards.

You will work with senior staff to support risk management, technical documentation, and regulatory filings to enable approvals across markets and ensure product safety and performance.

Qualifications

• 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.
• Understanding of and adherence to FDA, ISO and IEC design control procedures, regulations and standards.

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, 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

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.

Baxter's Front Line Care business unit products expand therapies to better help patients and physicians to monitor & manage chronic or acute respiratory and cardiac diseases (COPD, CHF, etc.). The earlier the treatment for these patients - the better the quality of life. The $1.1B business portfolio includes products for airway clearance, cardiology & patient monitors. The role of Engineer II 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 establishing compliance to codes and standards applicable to the product. You will also provide guidance to other engineers for technical issues, design reviews, and complex problem resolution.

Essential Duties & 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, 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

Qualifications

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.

Education and Experience

• 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