Senior Manager, Software Quality Assurance

LivaNova • Houston, TX

1d • Remote

About The Position

As Senior Manager, Software Quality Assurance, you will lead the software quality function and apply hands-on software development knowledge to ensure product software, firmware, and digital health platform services are designed, developed, verified, validated, and released in compliance with applicable quality system procedures. You will provide strategic and operational leadership to software quality engineers, drive continuous improvement in software quality processes, and ensure robust risk management throughout the software lifecycle. You and your team will partner with key stakeholders, contribute to design history file content, and, where relevant to your expertise, lead post-market product investigations, CAPAs, and audit support.

This is a full-time, remote position that may include up to 25% travel. The role offers an opportunity to directly impact product quality and improve the user experience at a growing medical device company specializing in neuromodulation products.

Requirements

• Bachelor’s degree in Computer Engineering, Computer Science, Electrical Engineering, or a related field.
• At least 8 years of medical device experience.
• At least 3 years of prior team management experience.
• Deep knowledge of software development principles, ISO 13485, IEC 62304, FDA QMSR, ISO 14971, and cybersecurity requirements.
• Demonstrated experience developing software or firmware in the medical device industry, combined with software quality leadership experience and demonstrated proficiency with IEC 62304 requirements.
• Technical capability in software development, preferably C or C#, including the ability to assess code reviews, software defects, verification results, and CAPA conclusions.
• Ability to lead strategy and provide technical direction for complex software investigations, CAPAs, quality decisions, and development-related risk assessments.

Nice To Haves

• Master’s degree or higher in engineering or a software-related discipline.

Responsibilities

• Recruit, mentor, coach, and develop software quality engineers.
• Lead software and firmware quality for product software and cloud infrastructure, including the digital health platform.
• Ensure design requirements, architecture and detailed design specifications, code review evidence, verification and validation evidence, risk management files, and traceability are complete and sufficient.
• Chair or oversee software change control boards and defect management processes.
• Communicate verification and validation results to management, including outcome summaries and known software anomalies.
• Build strategic alignment with R&D, Regulatory, Operations, Security, Marketing, and Clinical organizations.
• Maintain working knowledge of program hazard analyses, FMEAs, security risk assessments, risk management reports, and post-market lifecycle risk documentation.
• Approve complex investigations, technical assessments, code-related quality conclusions, and quality-critical decisions.
• Manage the team to ensure on-time delivery of investigations, CAPAs, and audit responses.
• Maintain and improve software development, test, and change management procedures, as well as digital health platform management practices.
• Ensure team members support compliant validation of manufacturing and test system software in new product development programs.
• Serve as a senior subject matter expert during internal audits and external regulatory inspections.
• Ensure the team produces complete design history files with the elements needed to demonstrate compliance.
• Communicate software quality status, risks, and mitigation strategies to senior leadership.
• Organize and support cross-functional efforts during field actions.
• Lead initiatives to strengthen software quality processes, tools, and metrics.

Benefits

• Discretionary annual bonus.
• Professional growth and development opportunities.
• Opportunities to collaborate with international partners and cross-functional teams.
• Competitive compensation.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior