Verification & Validation Engineer

Capgemini • Chicago, IL

1d • Onsite

About The Position

We are seeking a detail-oriented and experienced Manual Testing Engineer to join our team, specializing in the medical domain. The ideal candidate will have hands-on experience in validating healthcare applications, with a strong understanding software verification and validation protocols and compliance standards. You will be responsible for verification and validating of product software, co-ordinating with the stake holders and offshore team, formal documentation, protocol creation and execution , requirement traceability.

Requirements

• Bachelor’s degree in engineering, Computer Science, Life Sciences, or related field.
• 3-5+ years of experience in manual testing within the medical device or healthcare domain.
• Experience in NPS (Non-Product Software)validation and understanding of software validation lifecycle.
• Strong documentation and communication skills.
• Ability to work independently in an onsite setup and coordinate with cross-functional teams.

Nice To Haves

• Experience with quality systems software (e.g., TrackWise, MasterControl, SAP).
• Knowledge of FDA 21 CFR Part 11, ISO 14971, and ISO 13485.
• ISTQB or equivalent QA certification.
• Exposure to risk-based validation approaches.

Responsibilities

• Perform manual testing of Product Software used in medical device environments (e.g., document management systems, ERP, LIMS, MES).
• Develop and execute test plans, test cases, and validation protocols in accordance with regulatory and quality requirements.
• Ensure traceability of requirements through RTM (Requirement Traceability Matrix).
• Collaborate with QA, IT, and business stakeholders to ensure software meets intended use and compliance standards.
• Document and manage defects using tools like JIRA, HP ALM, or similar.
• Support audits and inspections by providing validation documentation and evidence.
• Maintain detailed records of testing activities and validation deliverables.

Benefits

• Paid time off based on employee grade (A-F), defined by policy: Vacation: 12-25 days, depending on grade, Company paid holidays, Personal Days, Sick Leave
• Medical, dental, and vision coverage (or provincial healthcare coordination in Canada)
• Retirement savings plans (e.g., 401(k) in the U.S., RRSP in Canada)
• Life and disability insurance
• Employee assistance programs
• Other benefits as provided by local policy and eligibility

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level