Navigation Systems Verification & Validation Engineering Manager

Jobtailor; Raynham (MA); On-site; USD 120,000 - 190,000; Full time

Job summary

Jobtailor is seeking a senior Verification and Validation engineer to lead V&V activities for complex medical devices. You will drive requirements traceability, develop test plans, and coordinate cross‑functional teams across systems, hardware, and software to ensure patient safety and regulatory compliance.

The role requires 7+ years in medical device V&V, strong systems engineering knowledge, and experience with DOORS, Jama, Polarion, Python, LabVIEW, and MATLAB.

Qualifications

• Bachelor’s or master’s degree in biomedical engineering, Systems Engineering, Electrical Engineering, or related field.
• 7+ years of experience in V&V engineering within the medical device industry.
• 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.

Responsibilities

• Lead a team of Verification & Validation and Integration Engineers to ensure navigation systems meet all defined subsystem‑and system‑level requirements.
• Collaborate closely with systems engineering, hardware, and software teams to ensure requirements are clearly defined, testable, and fully traceable from user needs and system/subsystem requirements through verification and validation.
• Define minimum testable requirements following design or requirement changes, applying a risk‑based approach that considers essential performance and basic safety.
• Develop and execute comprehensive V&V strategies and master system test plans for complex medical devices, including system verification protocols and regression strategies to ensure robust requirements coverage.
• 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.
• Coordinate and manage engagement with external test facilities (e.g., NRTLs, EMC, and restricted‑materials laboratories) to ensure full regulatory compliance and adherence to internal company policies.
• Oversee the maintenance of navigation systems 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.

Skills

Verification And Validation

Regulatory Compliance

Systems Engineering

Technical Writing

Leadership

Root Cause Analysis

Test Method Design

Risk-Based Approach

Education

Bachelor’s or Master’s in Biomedical Engineering, Systems Engineering, Electrical Engineering

Tools

DOORS

Jama

Polarion

Python

LabVIEW

MATLAB

Job description

Requirements

• Bachelor’s or master’s degree in biomedical engineering, Systems Engineering, Electrical Engineering, or related field.
• 7+ years of experience in V&V engineering within the medical device industry.
• 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.

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 comprehensive V&V strategies and managing cross-functional teams to ensure product quality and safety.

• Lead a team of Verification & Validation and Integration Engineers to ensure navigation systems meet all defined subsystem‑and system‑level requirements.
• Collaborate closely with systems engineering, hardware, and software teams to ensure requirements are clearly defined, testable, and fully traceable from user needs and system/subsystem requirements through verification and validation.
• Define minimum testable requirements following design or requirement changes, applying a risk‑based approach that considers essential performance and basic safety.
• Develop and execute comprehensive V&V strategies and master system test plans for complex medical devices, including system verification protocols and regression strategies to ensure robust requirements coverage. This includes oversight of investigational, integration, reliability, and formal verification and validation 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.
• Coordinate and manage engagement with external test facilities (e.g., NRTLs, EMC, and restricted‑materials laboratories) to ensure full regulatory compliance and adherence to internal company policies.
• Oversee the maintenance of navigation systems 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.
• For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, 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.

Hard Skills

• Verification And Validation Engineering
• Requirements Management Tools
• Test Automation Tools
• Systems Engineering Principles
• Risk-Based Approach
• Technical Writing
• Root Cause Analysis
• Test Method Design
• Product Development Lifecycle
• Regulatory Standards Compliance

Soft Skills

• Excellent Communication Skills
• Team Leadership
• Problem Solving
• Collaboration
• Project Management

Industry Keywords

• Medical Device Industry
• V-Model
• Waterfall
• Agile
• Health, Safety And Environmental Practices

Tools & Technologies

• DOORS
• Jama
• Polarion
• Python
• LabVIEW
• MATLAB