Sr. Test Engineer

Qualitest is hiring for B1 grade:

• Verification and Validation of software for complex system interactions in medical devices, includingo Application softwareo Embedded softwareo Platform softwareo Operating system software

• With minimal assistance, develop and execute manual and/or automated software verification protocols, including:

o Design and development of test scenarioso Authoring and review of test cases and protocols

o Performing execution of test caseso Writing reports

• Responsible for verification of the software platform of the medical device, including:

o User interface and interactions

 o Performance and reliability

 o Safety and interoperability

• Ability to review and understand product and software requirements

• Effectively communicate issues observed while documenting the same with necessary details

 • Assist in reproducing and analyzing potential defects found in testing

 • A good understanding of standard operating procedures for medical device development, including compliance with ISO 13485 and IEC 62304

• Engaging in continuous improvement initiatives to establish Center of Excellence (CoE) in Software Assurance function. REQUIREMENTS/PREFERENCESMandatory Requirements:

• Minimum of 2 years of relevant work experience in software testing in medical device or in a regulated industry.

• Thorough knowledge of the software testing lifecycle with the ability to design and execute test protocols effectively.

• Foundational coding skills in languages commonly used in test automation (e.g., Python, Java, or C#).

• The candidate is expected to work from the office.

Skill & Competency Requirements:

 • Bachelor’s degree in engineering, preferably Computer, Electronics, or Biomedica

l• Exposure to software test automation and ability to adapt and learn test automation.

 • Strong attention to detail and ability to follow instructions

 • Familiarity with Software Development Lifecycle processes, including Waterfall and Agile methodologies

 • Technical writing ability – clear and concise writing easily understood by multiple audiences (testers, auditors, peers, etc.)

• Have a strong sense of ownership and project outcome.

Preferences:

 • Exposure to designing and developing medical device software in a regulated environment while adhering to FDA Design Controls and software process guidelines for medical devices including ISO 13485 and IEC 62304

• Working knowledge of tools such as Rational Quality Manager, Jenkins, TOSCA, Squish, JIRA, Git and DOORS Next Gen

• Working knowledge on OS such as Windows, Linux flavors

• Demonstrated ability working in a matrix/hybrid organization structure

• Ability to troubleshoot and make quick knowledge and experience-guided decisions

• Excellent written and oral communication

• Excellent people skills, ability to partner well, good team camaraderie

• Proficient with Microsoft Office tools especially MS Word, MS Excel, MS PowerPoint, MS Project, and other management tools