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| COMPANY | : | [ BAXTER ] |
| ROLE | : | [ Principal Engineer Test ] |
| VACANCY | : | [ 16+ ] |
| QUALIFICATION | : | [ BE /ME /BTECH /MTECH /DIPLOMA(Mechanical/Electrical/Software/Computer Science/Biomedical Engineering) Or Engineering Related Field ] |
| EXPERIENCE | : | [ 12 To 15 Years ] |
| SALARY | : | [ Upto Rs 5,25,000 to Rs 12,40,000 / Year ] |
| LOCATION | : |
[ Bangalore ] |
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ABOUT COMPANY :
Baxter was founded in 1931, however our history doesn't have one starting point. Our commitment to addressing unmet needs was built on the shoulders of healthcare pioneers whose work resulted in first-of-its-kind innovations in IVs, renal care, nutrition, respiratory, hospital beds and today's connected care.
JOB DESCRIPTION :
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Your Role at Baxter:
Baxter’s suite of diagnostic cardiology solutions of the Front Line Care business unit products are standard of care for improving diagnostic yield, workflow efficiency, and long-range patient outcomes. The products include intelligent and connected devices that utilize advance sensing capabilities to generate differentiated insights across key heart conditions (e.g. Arrythmia, MI, CHF). Further, connected solutions through vendor neutral shared platforms (i.e. Epiphany) can streamline workflows, EMR integration and care pathways across the patient journey. Additionally, Clinical, and remote services augment and support clinician and staff processes and services to provide actionable data on patients and devices. And finally, AI aided diagnosis and decision support capabilities improve diagnostic yields and efficiencies.
The $130M business portfolio includes the ELI Resting ECG systems, Holter analysis and recorders, stress ECG diagnostics, spirometry diagnostics and data management systems that represent the standard of care for diagnostic cardiology .
Position Overview
A Principal Engineer, V&V will be responsible for verification of cardiology products and providing creative solutions for our new and existing product portfolio. The successful candidate will possess solid “hands-on” technical abilities, an excitement and energy for product development, and a passion for their work and the impact it has on meeting the needs of patients.
Essential Duties and Responsibilities:
- Formulate end to end system verification strategy for a product. Takes complete ownership of testing a product or release and ensures high quality deliverables.
- Proven experience in delivering medical devices to meet IEC/FDA/ISO standards and working closely with the regulatory bodies and affiliated labs.
- Develop automation strategy and framework for the Software and System level testing.
- Author, execute, perform, summarize, report out verification & validation test activities of components of a full system device; which includes but not limited to: Test Plans, Test Procedures, User and Functional Requirements testing, Design Verification, Installation/Operational/Performance Qualification Protocols, Traceability Matrices and Final Reports.
- Pair up with design & development team to start the testing early in the design cycle to ensure the requirements testability, design traceability & test coverage. Refine the test plans and procedures through pre-verification/dry runs.
- Identify and report any quality or compliance concerns and take immediate corrective/ preventive action as needed.
- Review work products and ensure the quality of deliverables.
- Participates in continuous improvement activities by identifying and appropriately escalating process and product quality gaps.
- Lead the qualification of lab area, drive productivity improvement efforts, including testing, building fixtures, calibration, and data collection.
- Ensures good documentation and good manufacturing practices are followed in the Verification and Validation Process.
- Leads the investigations by identifying the root cause and drive solutions.
- Leads the regulatory responses and audits (internal and external) from the front. Adheres to Baxter Quality Management system & front ends the quality audits.
- Participates in and contributes to the roadmap discussion.
- Mentor peers/engineers in the stream of their expertise and on the processes.
Qualifications / Experience and/or Background
- Bachelor's Degree in Mechanical engineering, Electrical Engineering, Software Engineering, Computer Science, Bio-Medical, Industrial Engineering or related field.
- 12 to 15 years of experience in Verification and validation testing of Software, Hardware and System.
- Experience in design verification and validation of medical devices; and understanding of and adherence to FDA, ISO and IEC design control procedures, regulations, and standards.
- Deep expertise in manual and automation testing. Well versed with software and system testing techniques.
- Experience in writing system, subsystem-level and module level verification and validation plans, procedures, test execution and test report generation.
- An understanding of test methods and processes as well as the methods used to verify product in the realms of software, mechanical, electrical, functional and environmental testing environments.
- Familiarity with reliability theory and analysis.
- Experience in technically leading a team of test engineers.
Personal Characteristics
- Excellent communication, inter-personal and leadership skills
- Firm decision maker and shall possess good influencing skills
- Openness to collaborate in interest of project/organization.
- Proactive and self-driven, possesses due sense of urgency
- Shall possess systems mindset and good problem-solving abilities.
- Working with multisite teams, Quality conscious and Process & customer Oriented
JOB DESCRIPTION : ( SAME DESCRIPTION ONLY USE TO PRINT OUT PERSON )
Your Role at Baxter:
Baxter’s suite of diagnostic cardiology solutions of the Front Line Care business unit products are standard of care for improving diagnostic yield, workflow efficiency, and long-range patient outcomes. The products include intelligent and connected devices that utilize advance sensing capabilities to generate differentiated insights across key heart conditions (e.g. Arrythmia, MI, CHF). Further, connected solutions through vendor neutral shared platforms (i.e. Epiphany) can streamline workflows, EMR integration and care pathways across the patient journey. Additionally, Clinical, and remote services augment and support clinician and staff processes and services to provide actionable data on patients and devices. And finally, AI aided diagnosis and decision support capabilities improve diagnostic yields and efficiencies.
The $130M business portfolio includes the ELI Resting ECG systems, Holter analysis and recorders, stress ECG diagnostics, spirometry diagnostics and data management systems that represent the standard of care for diagnostic cardiology .
Position Overview
A Principal Engineer, V&V will be responsible for verification of cardiology products and providing creative solutions for our new and existing product portfolio. The successful candidate will possess solid “hands-on” technical abilities, an excitement and energy for product development, and a passion for their work and the impact it has on meeting the needs of patients.
Essential Duties and Responsibilities:
- Formulate end to end system verification strategy for a product. Takes complete ownership of testing a product or release and ensures high quality deliverables.
- Proven experience in delivering medical devices to meet IEC/FDA/ISO standards and working closely with the regulatory bodies and affiliated labs.
- Develop automation strategy and framework for the Software and System level testing.
- Author, execute, perform, summarize, report out verification & validation test activities of components of a full system device; which includes but not limited to: Test Plans, Test Procedures, User and Functional Requirements testing, Design Verification, Installation/Operational/Performance Qualification Protocols, Traceability Matrices and Final Reports.
- Pair up with design & development team to start the testing early in the design cycle to ensure the requirements testability, design traceability & test coverage. Refine the test plans and procedures through pre-verification/dry runs.
- Identify and report any quality or compliance concerns and take immediate corrective/ preventive action as needed.
- Review work products and ensure the quality of deliverables.
- Participates in continuous improvement activities by identifying and appropriately escalating process and product quality gaps.
- Lead the qualification of lab area, drive productivity improvement efforts, including testing, building fixtures, calibration, and data collection.
- Ensures good documentation and good manufacturing practices are followed in the Verification and Validation Process.
- Leads the investigations by identifying the root cause and drive solutions.
- Leads the regulatory responses and audits (internal and external) from the front. Adheres to Baxter Quality Management system & front ends the quality audits.
- Participates in and contributes to the roadmap discussion.
- Mentor peers/engineers in the stream of their expertise and on the processes.
Qualifications / Experience and/or Background
- Bachelor's Degree in Mechanical engineering, Electrical Engineering, Software Engineering, Computer Science, Bio-Medical, Industrial Engineering or related field.
- 12 to 15 years of experience in Verification and validation testing of Software, Hardware and System.
- Experience in design verification and validation of medical devices; and understanding of and adherence to FDA, ISO and IEC design control procedures, regulations, and standards.
- Deep expertise in manual and automation testing. Well versed with software and system testing techniques.
- Experience in writing system, subsystem-level and module level verification and validation plans, procedures, test execution and test report generation.
- An understanding of test methods and processes as well as the methods used to verify product in the realms of software, mechanical, electrical, functional and environmental testing environments.
- Familiarity with reliability theory and analysis.
- Experience in technically leading a team of test engineers.
Personal Characteristics
- Excellent communication, inter-personal and leadership skills
- Firm decision maker and shall possess good influencing skills
- Openness to collaborate in interest of project/organization.
- Proactive and self-driven, possesses due sense of urgency
- Shall possess systems mindset and good problem-solving abilities.
- Working with multisite teams, Quality conscious and Process & customer Oriented
How to apply :
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