Job Description

HCLTech is looking for a highly talented and self- motivated Software Tool Verification and Validation Engineer to join it in advancing the technological world through innovation and creativity.

Job Title: Software Tool Verification and Validation Engineer

Job ID: 1628481BR

Position Type: Hybrid -Onsite 3 days a week

Location: Newton,MA

Job Title: Software Tool Verification and Validation Engineer

Job Summary

We are seeking a detail-oriented Software Tool Verification and Validation Engineer to ensure the reliability, accuracy, and compliance of software tools used in development and production environments. This role involves planning, executing, and documenting validation activities in accordance with industry standards and regulatory requirements

Key Responsibilities

• 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.
• Good communication and teamwork skills.

Pay and Benefits

Pay Range Minimum: $ 79,000 per year

Pay Range Maximum: $ 116,000 perYear

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 secure@hcltech.com for investigation.

A candidate’s pay within the range will depend on their skills, experience, education, and other factors permitted by law. This role may also be eligible for performance-based bonuses subject to company policies. In addition, this role is eligible for the following benefits subject to company policies: medical, dental, vision, pharmacy, life, accidental death & dismemberment, and disability insurance; employee assistance program; 401(k) retirement plan; 10 days of paid time off per year (some positions are eligible for need-based leave with no designated number of leave days per year); and 10 paid holidays per year

How You’ll Grow

At HCLTech, we offer continuous opportunities for you to find your spark and grow with us. We want you to be happy and satisfied with your role and to really learn what type of work sparks your brilliance the best. Throughout your time with us, we offer transparent communication with senior-level employees, learning and career development programs at every level, and opportunities to experiment in different roles or even pivot industries. We believe that you should be in control of your career with unlimited opportunities to find the role that fits you best.

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