- Collaborate with systems engineering to ensure requirements clarity, testability, and traceability from user needs, system and sub-system requirements, through verification and validation.
- Define minimum testable requirements post-change (risk-based, essential performance, basic safety).
- Develop and execute comprehensive V&V strategies and master system test plans for complex medical devices, including system verification protocols and regression plans that ensure robust requirements coverage; this includes investigational, integration, reliability, and formal V&V testing.
- 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, including manual and automated test setups, to ensure they are suitable for verifying product requirements, including repeatability, 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.
- Ensure compliance with regulatory standards (e.g., FDA 21 CFR Part 820, ISO 13485, IEC 60601, ISO 14971).
- Support design transfer and 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.
- Identify critical paths during product development, address bottlenecks and risks and facilitate problem solving across R&D teams.
- Support project resource and schedule planning.
Requirements
- Bachelor’s or master’s degree in biomedical engineering, Systems Engineering, Electrical Engineering, or related field.
- 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.
- Strong understanding of systems engineering principles and product development lifecycle (e.g., V-model, waterfall, Agile).
- 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.
- Proficient in sample size calculation and statistical methods for analyzing data.
Core Competencies
Demonstrates expertise in Verification and Validation (V&V) engineering for medical devices, with a strong focus on regulatory compliance, systems engineering principles, and effective communication. Proficient in developing test strategies and managing requirements throughout the product development lifecycle.
Highest-signal resume keywords
- Verification And Validation Engineering
- Medical Device Industry Experience
- Requirements Management Tools
- Regulatory Compliance (FDA, ISO)
- Test Automation Tools
ATS Optimization Keywords
Hard Skills
- V&V Strategies
- Test Method Design
- Statistical Analysis
- Embedded Systems Testing
- Firmware/Software Testing
Soft Skills
- Technical Writing
- Communication Skills
- Problem Solving
Certifications & Qualifications
- CQE
- CQA
- Six Sigma
Industry Keywords
- Biomedical Engineering
- Systems Engineering
- Class II Medical Devices
- Class III Medical Devices
- Product Development Lifecycle
Tools & Technologies
- DOORS
- Jama
- Polarion
- Python
- LabVIEW
- MATLAB