Firmware Integration & Verification (V&V) Lead Engineer

PIXIE; Wisconsin; On-site; USD 120,000 - 180,000; Full time

Job summary

PIXIE is seeking an experienced Firmware Integration & Verification (V&V) Lead Engineer to join our medical device engineering team in Wisconsin. You will lead firmware integration across hardware, firmware, and software subsystems and drive V&V strategy through the product lifecycle.

You will collaborate with cross-functional teams to ensure design control, QMS compliance, and DHF documentation, while championing CI/CD and automated testing practices to improve quality and

Qualifications

• Bachelor’s degree in engineering or STEM required.
• 10+ years in firmware/embedded systems or verification.
• Experience in regulated product development.
• Knowledge of QA/QMS and DHF.
• Experience with CI/CD and automated testing.

Responsibilities

• Lead firmware integration across hardware, firmware, and software subsystems.
• Drive V&V strategy, planning and documentation.
• Represent firmware during design control activities.
• Define integration requirements and verification plans across multiple teams.
• Champion CI/CD and automated testing practices.
• Collaborate with cross-functional teams to identify risks and dependencies.
• Ensure QMS compliance and support DHF documentation.
• Assist ALM administration and traceability.
• Troubleshoot complex integration issues.
• Prepare verification reports and engineering deliverables.
• Coordinate with global teams across locations.

Skills

Firmware integration

V&V leadership

Design control

QA/QMS awareness

Cross-functional collaboration

Education

Bachelor's degree in Engineering or STEM

Tools

ALM

ClearQuest

Rally

Job description

We are seeking an experienced Firmware Integration & Verification (V&V) Lead Engineer to join a cutting-edge medical device engineering team. This role is responsible for leading firmware integration, system verification and validation (V&V), and design control activities throughout the product development lifecycle. The ideal candidate will have extensive experience integrating complex hardware, firmware, and software systems while ensuring compliance with quality and regulatory requirements in a highly regulated environment.

Key Responsibilities

• Lead firmware integration activities across hardware, firmware, and software subsystems.
• Drive Verification & Validation (V&V) strategy, planning, execution, and documentation throughout the development lifecycle.
• Represent the Firmware Engineering team during all phases of design control, including requirements definition, design planning, verification, validation, and product release.
• Define integration requirements, verification plans, and execution strategies while coordinating controlled integration activities across multiple engineering teams.
• Champion Continuous Integration (CI), Continuous Deployment (CD), and automated testing practices to improve software quality and development efficiency.
• Partner with cross-functional engineering teams to identify technical risks, system dependencies, design trade-offs, and mitigation strategies.
• Ensure compliance with Quality Management System (QMS) processes and support Design History File (DHF) documentation and product release activities.
• Serve as the Application Lifecycle Management (ALM) administrator, supporting requirements traceability, defect tracking, and test management.
• Troubleshoot and debug complex hardware, firmware, and software integration issues.
• Prepare and maintain technical documentation, verification reports, and engineering deliverables.
• Collaborate effectively with global engineering teams across multiple locations and time zones.

Required Qualifications

• Bachelor's degree in Engineering, Computer Engineering, Electrical Engineering, Computer Science, or another STEM discipline.
• 10+ years of experience in firmware, embedded systems, systems integration, or verification engineering.
• Strong experience integrating hardware, firmware, embedded software, and system-level solutions.
• Proven experience leading Verification & Validation (V&V) activities within regulated product development environments.
• Deep understanding of Design Control, Quality Management Systems (QMS), and Design History Files (DHF).
• Experience with Continuous Integration (CI), Continuous Deployment (CD), and automated testing methodologies.
• Strong debugging and troubleshooting experience across hardware, firmware, and software environments.
• Demonstrated success leading technical projects and collaborating with cross-functional engineering teams.
• Excellent analytical, problem-solving, and communication skills.
• Experience using ALM, ClearQuest, Rally, or similar engineering lifecycle management tools.

Preferred Qualifications

• Experience within the Medical Device industry, particularly CT, MRI, Imaging Systems, or other regulated healthcare technologies.
• Familiarity with FDA-regulated product development and medical device quality standards.
• Experience working with globally distributed engineering teams.
• Proven ability to influence technical decisions, manage complex integrations, and deliver projects on schedule.