Senior Enterprise Software Test Engineer

Senior Enterprise Software Test Engineer

A Day in the Life

You will drive software quality and patient safety by:

• Operating in all phases

  and contributing to all activities of the software development process.

• Reading, analyzing, and thoroughly understanding product requirements

  .
• Actively

  participating in story grooming

  sessions to ensure clear and testable requirements.

• Participating in test case documentation and reviews

  , ensuring comprehensive coverage.

• Learning and understanding software standards for Medical devices

  , specifically IEC 60601-1, IEC 62304, ISO 13485, ISO 14971, and applicable FDA standards.
• Working under general direction and

  collaboratively with internal and external partners

  across global R&D teams.
• Performing

  Software Verification & Validation (V&V)

  using both manual and automation methodologies.
• Being

  proficient in automation testing

  of Desktop, Web, and Mobile applications using the latest tools and technologies (e.g., LabVIEW, Selenium, Appium).
• Being

  flexible and capable of performing both Manual and Automation testing

  as needed.

• Working in a cross-functional Agile team

  to test software for new and existing medical device products.

• Thoughtfully developing testing strategies and protocols

  with state-of-the-art software best practices.

• Reviewing test designs and validating test scripts

  for the verification of software used in Acute Care Monitoring.

• Participating in reviews of requirements, design, implementation, and testing

  to ensure quality standards are met.

• Developing, documenting, and testing software

  to ensure it meets end-user needs and business goals.

• Providing support for Non-Product Tool Validation (NPTV)

  .

• Documenting results of defect analysis

  and providing support to development teams.

• Participating in other quality assurance functions

  , including static code analysis, risk/hazard analysis, and test automation development.

• Meeting key business KPIs and project metrics

  .

• Mentoring other V&V team members

  when needed.

Required Knowledge and Experience

• B.E./B.Tech./M.E./M.Tech. in Computer Science, Biotechnology, Biomedical, Electronics, or Electrical Engineering.

• 10 to 12 years of experience in Embedded Software Verification & Validation

  , with at least two (2) years of experience in the medical device/medical IT or regulated industry.

• Strong proficiency in programming languages

  such as

  Python and C#

  .

• Solid understanding of software testing principles, methodologies, and techniques.

• Ability to

  develop and implement automated test scripts

  for Desktop, Web, Mobile, and Embedded applications using industry-standard tools and frameworks.
• Experience in both

  white-box and black-box testing

  , with strong debugging skills.
• Experience working in a

  structured software development environment

  following a well-defined process (e.g., Agile or Lean).

• Excellent debugging and problem-solving skills.

• Experience with

  tools such as JIRA, Polarion

  , and other relevant project and test management tools.
• Knowledge of

  LabVIEW, Selenium, and Appium.

• Experience in

  hardware/software interfacing and design issues.

• Experience/knowledge of

  networking protocols and standard embedded communication protocols

  (e.g., SERIAL UART, USB, Bluetooth, and Wi-Fi).
• Experience with

  continuous integration and deployment tools

  (e.g., GitLab).

• Awareness of medical device standards

  , including IEC 60601-1, IEC 62304, ISO 13485, ISO 14971, and applicable FDA standards.

• Design/development experience working with regulated medical devices.

• Experience working within a

  regulated environment.

• Experience with

  software version control tools.

• Possesses qualities such as being positive, maintaining high standards, resilience, openness, and creativity.
• Quality focus, willingness to learn, versatility, and adaptability.

Principal Working Relationship: