Navigation Systems V&V Engineering Manager

About Orthopaedics

Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments. Our Orthopaedics teams help keep more than 6 million people moving each year while delivering clinical and economic value to surgeons and healthcare systems. Our teams build solutions for joint reconstruction; trauma and craniomaxillofacial; sports, extremities, and elective foot and ankle; spine; and robotics and digital surgery.

Purpose

The Navigation Systems Verification & Validation (V&V) Engineering Manager is responsible for ensuring that navigation products meet all defined system- and subsystem-level requirements and are safe, effective, and compliant for their intended clinical use. This role plays a critical part in supporting regulatory submissions and product releases by planning, executing, and documenting comprehensive V&V activities in accordance with FDA regulations, ISO 13485, IEC standards, and other applicable regulatory and quality system requirements. The Navigation Systems V&V Engineering Manager leads a team of Verification & Validation and Integration Engineers, providing technical and people leadership to ensure that navigation systems meet all subsystem- and system-level requirements throughout development and release. Working cross-functionally with systems, software, hardware, clinical, navigation, manufacturing, and quality teams, the Navigation Systems V&V Engineering Manager ensures that design outputs are thoroughly verified and validated against user needs, intended use, system and subsystem requirements, and risk controls.

Job 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, including 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.
• Review and approve 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 and 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.
• 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.
• Identify critical paths during product development, address bottlenecks and risks and facilitate problem solving across R&D teams.
• Support project resource and schedule planning.

Qualifications

Required:

• 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.

Preferred:

• Experience with Class II or Class III medical devices is preferred.
• Knowledge of embedded systems, firmware/software testing, or electromechanical systems is a plus.
• Experience in surgical robotics or surgical navigation technologies is a major plus.
• Certification in CQE, CQA, or Six Sigma is a plus.
• Proficient in sample size calculation and statistical methods for analyzing data.