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:
Design and development of test scenarioso Authoring and review of test cases and protocols
Performing execution of test caseso Writing reports
Responsible for verification of the software platform of the medical device, including:
User interface and interactions
Performance and reliability
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
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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
