Medical Device Software Validation Engineer

7 days ago

Bengaluru, Karnataka, India Baxter Full time
Job Overview
Baxter is a leading medical technology company that offers innovative products and therapies. We are seeking a skilled Medical Device Software Validation Engineer to join our team. As a software validation engineer, you will play a critical role in ensuring the quality and safety of our medical devices.

About Us
Baxter has a long history of pioneering significant medical innovations that transform healthcare. Our products and therapies are found in almost every hospital worldwide, and we are committed to improving patient outcomes. At Baxter, you'll have the opportunity to work with talented professionals who share your passion for making a positive impact on people's lives.

Your Role at Baxter
As a Medical Device Software Validation Engineer, you will be responsible for reviewing, authoring, implementing, performing, summarizing, and reporting out SW verification & validation test activities for components of a Software application. This includes but is not limited to:
  • Design and develop model verification test protocols and procedures/scripts from requirement specifications.
  • Organize and implement test protocols and test procedures/scripts for embedded software.
  • Share technical knowledge within the team.
  • Collect and analyze test results from model testing activities.
  • Work closely with the software/model development team in reviewing specifications, writing test procedures, plans, entering product issues, and collecting completed test data/documentation for archiving.
  • Use MATLAB and Simulink Test for model-based testing activities.
  • SUPPORT compliance/CLOSURE of Regulatory and Quality requirements before completing Design Outputs/Program Deliverables.
  • CLEAR understanding of the elements of Risk Management, FMEA, Software reliability, and related V&V tasks.
  • Participate in the development of Verification & Validation methodologies in accordance with applicable Quality/Regulatory requirements and industry standard methodologies.
  • Diagnose, isolate, and investigate problem reports. Drive product software improvements and/or bug fixes. Drive impact analysis by reviewing code changes for each release.
  • Ensure good documentation practices are followed in the Verification and Validation Process.
  • Adhere to Baxter Quality Management system & support quality audits.
  • Pair up with design & development team to start the testing early in the design cycle to ensure the requirement's testability, design traceability & test coverage. Identify issues early to fix them. Refine the test plans and procedures through pre-verifications / Dry runs.
  • Interact with design team to resolve tests-related technical issues.
  • Present the findings/objective evidence and able to present with rationale with applicability/exclusions.
  • Identify and report any quality or compliance concerns and take immediate corrective/preventive action as needed.

What You'll Bring
To be successful in this role, you will need to have a Bachelor's degree in mechanical engineering, Electrical Engineering, Software Engineering, Computer Science, Bio-Medical, Industrial Engineering or related field or equivalent. You will also need to have 6 to 9 yrs of experience in Verification and validation testing of Software and System. Proven experience with the MATLAB and Simulink Test software is required, preferably hands-on experience in building test models using MATLAB or Simulink. Minimum 2 years of model-based test development and testing experience or equivalent education is necessary. Experience working with Simulink model test harnesses is also desired. Knowledge of Microsoft Office (Word, Excel, Outlook, Teams, etc.) is essential. 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 is necessary. Experience in - writing Software, subsystem-level, and module level verification and validation plans, procedures, Test Execution, and Test report generation is required. Understanding of software product design methodologies and test practices is necessary. Familiarity with reliability theory and analysis as it pertains to test quantities derived from reliability is desirable. Experience in medical device or similar product development, design verification/validation, Software integration, risk management, reliability engineering, process validation, and Quality systems is preferred. Deep expertise in design verification and validation of medical devices is a plus. Understanding of and alignment to FDA, ISO, and IEC design control procedures, regulations, and standards is necessary. Proven experience in accomplishing objectives. Able to deliver on multiple projects simultaneously. Self-motivated with good interpersonal skills.

Estimated Salary Range
$120,000 - $180,000 per year.

Benefits
Baxter offers a comprehensive benefits package, including health insurance, retirement savings plan, paid time off, and opportunities for professional growth and development.

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