Verification & Validation Lead (Medical Devices / CI-CD / ALM)

Job Description

We are seeking an experienced Firmware Integration & Verification & Validation (V&V) Lead to support CT system development. In this role, you will drive firmware integration, lead V&V activities, and ensure alignment with quality and regulatory standards. You will work cross-functionally to manage technical execution, mitigate risks, and deliver high-quality solutions within defined timelines.

This position requires strong leadership, hands-on technical expertise, and the ability to operate across hardware, firmware, and software domains in a regulated environment.

Key Responsibilities

• Represent the Firmware team throughout the full design control lifecycle—from requirements definition and planning through product release.

• Lead integration strategy, including defining integration requirements and managing controlled integration across subsystems.

• Own end-to-end Verification & Validation (V&V) activities, including planning, execution, and reporting.

• Drive and support CI/CD pipelines and continuous testing frameworks to enhance development efficiency and product quality.

• Collaborate with cross-functional and global teams to identify and manage technical risks, dependencies, and design trade-offs.

• Ensure compliance with Quality Management System (QMS) requirements and support Design History File (DHF) documentation and release.

• Act as ALM administrator, enabling effective requirements management, traceability, and test execution.

• Troubleshoot and debug complex issues across hardware, firmware, and software layers.

• Provide clear technical documentation and communication to stakeholders.

Required Qualifications

• Bachelor’s degree in STEM (Science, Technology, Engineering, Mathematics).

• 10+ years of experience in firmware, systems integration, or V&V within complex environments.

• Strong background in hardware-software system integration, preferably in regulated industries such as medical devices (CT, MR, or similar).

• Proven leadership experience driving cross-functional technical initiatives.

• Hands-on experience with CI/CD, integration workflows, and test automation.

• Strong analytical and problem-solving skills with the ability to proactively mitigate risks.

• Experience with tools such as ALM, ClearQuest, Rally, or similar.

Preferred Qualifications

• Experience working in global, distributed teams across multiple time zones.

• Familiarity with regulatory and compliance standards in medical device environments.

• Strong ability to influence stakeholders and drive strategic technical decisions.