Test Lead - Embedded Device Testing

Be among the first 25 applicants. This role is contracted through a third‑party whose employees provide services to HCLTech and/or its clients. A valid work authorization to work in the United States is required. The expected pay range for this contract assignment is $44.00/hr - $47.00/hr, based on skills, experience, and location.

$44.00/hr - $47.00/hr

• Develop and execute verification and validation plans, protocols, and test cases for software and hardware tools.
• Collaborate with cross‑functional teams to define validation requirements.
• Perform risk assessments and impact analyses for software changes.
• Document verification and validation results and maintain traceability matrices.
• Ensure compliance with relevant standards (e.g., FDA 21 CFR Part 11, ISO 13485, GAMP
  5).
• Support audits and inspections by providing validation documentation.
• Develop comprehensive test plans, test cases, and test scripts based on software requirements and design specifications.
• Ensure test plans cover all functional and non‑functional requirements, including performance, reliability, and security.
• Execute manual and automated tests to identify software application defects.
• Conduct regression testing and exploratory testing to maintain existing functionality and uncover potential issues.
• Document test results, generate test reports, and log defects for regulatory compliance.
• Communicate test outcomes and defect status to development teams and management.
• Work closely with software developers and systems engineers to understand software requirements and functionality.

• Minimum of 7+ years of experience in software testing, preferably in the medical device industry.
• Experience with testing tools and frameworks (e.g., Clear Quest, Jama).
• Familiarity with regulatory standards and guidelines for medical devices (e.g., FDA 21 CFR Part 820, ISO 13485, IEC 62304).
• Strong understanding of software development and testing methodologies.
• Excellent analytical and problem‑solving skills.
• Attention to detail and a high level of accuracy.
• Proficiency in scripting or programming languages (e.g., Python, Java) for test automation.

Bachelor's degree in Computer Science, Software Engineering, Biomedical Engineering, or a related field.

HCLTech is an equal opportunity employer, committed to providing equal employment opportunities to all applicants and employees regardless of race, religion, sex, color, age, national origin, pregnancy, sexual orientation, physical disability or genetic information, military or veteran status, or any other protected classification, in accordance with federal, state, and/or local law. Should any applicant have concerns about discrimination in the hiring process, they should provide a detailed report of those concerns to  for investigation.