- 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.
- Test Planning and Design
- 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.
Test Execution - Execute manual and automated tests to identify software application defects.
- Conduct regression testing to ensure existing functionalities remain unaffected by new changes.
- Perform exploratory testing to uncover potential issues not identified by formal test cases.
Documentation and Reporting - Document test results, including detailed descriptions of defects and steps to reproduce them.
- Generate and maintain test reports, defect logs, and other documentation required for regulatory compliance.
- Communicate test outcomes and defect status to development teams and management.
Collaboration - Work closely with software developers, and systems engineers, to understand software requirements and functionality.
- Compliance and Standards
- Ensure testing activities comply with relevant regulatory standards (e.g., FDA, ISO 13485, IEC 62304).
- Stay updated with industry best practices and evolving regulatory requirements for medical device software.
Qualifications Education Bachelor's degree in Computer Science, Software Engineering, Biomedical Engineering, or a related field. Experience - Minimum of 7+ years of experience in software testing, preferably in the medical device industry.
- Experience with testing tools and frameworks (e.g., ClearQuest, Jama).
- Familiarity with regulatory standards and guidelines for medical devices (e.g., FDA 21 CFR Part 820, ISO 13485, IEC 62304).
Skills and Competencies - 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.
|
HCLTech is not the employer for this role. This work is contracted through a third-party whose employees provides services to HCLTech and/or its clients.
Candidates interested in applying for this Contract opportunity must have a valid work authorization to work in the United States. We do not accept agency resumes and are not responsible for any fees related to unsolicited resumes. Candidates who are currently employed by a client of HCLTech may not be eligible for consideration, as decided on an individualized basis depending upon business considerations.
The expected pay range for this contract assignment is shown above with the Job details. The exact pay rate will vary based on skills, experience, and location and will be determined by the third-party employer.
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.
Never miss an opportunity! Create an alert based on the job you applied for.