V&V Engineer

• Collaborate with systems and software engineering to ensure requirements clarity, testability, and traceability from user needs, system and sub-system requirements, through verification and validation.
• Develop and execute comprehensive verification protocols and regression plans covering investigational, integration, reliability, and formal V&V testing. Ensure thorough requirements coverage and verify that products meet specified requirements and acceptance criteria.
• Effective testing of applications during the Software Development Lifecycle including design, implementation, and execution
• Responsible for ensuring that all software and system test tools are appropriately validated, including assessing the applicability and criticality of GxP and 21 CFR Part 11 requirements if applicable.
• Responsible for defect creation, reproduction, verification, evidence collection, and reporting in accordance with quality system procedures.
• Prepare and deliver system-level V&V documentation, including summary reports and verification results. Reviewing and approving sub-system verification deliverables to ensure alignment with overall system requirements.
• Design, validate, and implement test methods as needed, including manual and automated test setups, to ensure they are suitable for verifying product requirements, including repeatability and reproducibility.
• Oversee the maintenance of robotics test lab facilities, ensuring all equipment and infrastructure are properly calibrated, serviced, and compliant with company safety, quality, and procedural standards; proactively identify and resolve issues to support uninterrupted testing and development workflows.
• Support product launch activities including complaints investigations. Investigate and document non-conformances, deviations, and test failures, drive root cause analysis and corrective actions.
• Interface with regulatory, quality, and manufacturing teams to support audits and inspections. Responsible for communicating business-related issues or opportunities to next management level
• Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.
• If applicable Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.
• Performs other duties assigned as needed
• Identify critical paths during product development, address bottlenecks and risks and facilitate problem solving across R&D teams.
• Support project resource and schedule planning
• Ensure compliance with regulatory standards (e.g., FDA 21 CFR Part 820, ISO 13485, IEC 60601, ISO 14971).
  

Desired Skills and Experience

EXPERIENCE AND EDUCATION
*Bachelor's or Master's degree
*3 years of experience in V&V engineering within the medical device industry.
*Experience with Class II or Class III medical devices is preferred.
*Knowledge of embedded systems, firmware/software testing, or electromechanical systems is a plus.

REQUIRED KNOWLEDGE, SKILLS
*Understanding of systems engineering principles and product development lifecycle
*Proficient in sample size calculation and statistical methods for analyzing data
*Experience with requirements management tools (e.g., DOORS, Jama, Polarion).
*Familiarity with test automation tools and scripting languages (e.g., Python, LabVIEW, MATLAB).
*Excellent technical writing and communication skills.
*Certification in CQE, CQA, or Six Sigma is a plus.

LOCATION & TRAVEL REQUIREMENTS
*Warsaw, IN
*In office expectations are a minimum of 3 days per week, up to 5 days per week depending on project demand.
*An estimate of travel up to 30% may be required both domestic and international

EOE Statement: Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

To find out more about Real, please visit www.realstaffing.com