Verification And Validation Engineer

Role/Summary:

Collaborate with cross-functional teams to identify and assess risks associated with medical device development and integrate risk management activities into the V&V process, ensuring that potential hazards and risks are adequately addressed and mitigated in accordance with ISO 14971.

Utilize risk-based testing methodologies to prioritize V&V activities based on the level of risk associated with medical devices.

Evaluate the effectiveness of risk controls and mitigation strategies through V&V testing activities.

Develop verification and validation protocols and test plans based on product requirements, design specifications, and regulatory standards.

Document and maintain comprehensive records of V&V activities, including test results, deviations, and corrective actions taken.

Ensure that V&V activities are integrated into the product development lifecycle and are compliant with regulatory requirements.

Ensure compliance requirements according to ISO 13485, CDSCO and EU MDR, ISO 14971 and other applicable regulations and standards.

Prepare and maintain V&V documentation for regulatory submissions, including technical files and design dossiers.

Experience with complete DHF development.

Job Responsibility:

Performs the role of a Verification Lead

Provide technical guidance, review support to the test team( manual and automation). Support & train test engineers on process/domain

Formulate the test strategy for a product/subsystem including test automation

Participates in Review of test deliverable.

Handle the estimation, planning , resource identification and risk management activities related to test automation.

Lead and participate in automation test case development, review, execution, reporting and traceability.

Ownership of completeness of all test documents

Manages technical communication within team and partners/stakeholders

Participates in improvement initiatives to enhance productivity

Drive the automation work within the team & aim to achieve committed automation coverage

Ownership of Test deliverable for the scope of work responsible

Mentor the junior testers on automation as Subject Matter Expert (SME).

Provide status update to management on overall Verification progress

Behavioral Competencies:

Firm decision maker and shall possess good influencing skills

Openness to collaborate in interest of project/organization

Proactive and self-driven, possesses due sense of urgency

Integrity & Corporate Values:

• Best in Class Is focused on Quality, and works with a mindset of continuous improvement
• Integrity – The job should be performed with the value of honesty, good principles, fairness and maintain confidentiality
• Open to Change – to have a creative mindset while performing one’s job, explore new processes and procedures to increase efficiency and effectiveness
• Respect - Gives respect in communication, work, collaboration with internal as well as external customers
• Alliance – Maintains timelines, understands the role one’s department plays across a larger picture, hence standing by commitments made to the team, other departments, vendors and external customers
• Diversity – Welcomes diversity as a stepping stone to innovation and builds stronger bonds with people to deliver better and more comprehensive results.