Senior Manager, Software Quality Assurance
Pay Transparency: A reasonable estimate of the annual base salary for this position is $150,000 - $175,000 plus discretionary annual bonus. Pay ranges may vary by location.
As our Senior Manager, Software Quality Assurance, you will lead the software quality function while applying 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 to provide cross-functional support, contribute to design history file content, and, where applicable to you areas of expertise, lead post-market product investigations, CAPAs, and provide audit support.. This is a full-time, remote position and may include up to 25% travel.
This is an opportunity to directly impact product quality and the improve user experience. LivaNova is a growing, cutting-edge, medical device company specializing in neuromodulation product the enrich patients lives.
What You'll Do
- Team Leadership and Development: Recruit, mentor, coach, and develop software quality engineers. Lead the software and firmware quality function for product software and cloud infrastructure, including the digital health platform.
- Design Control Oversight: Ensure the completeness and sufficiency of design requirements, architecture specifications, detailed design specifications, code review evidence, verification and validation evidence, risk management files, and traceability.
- Change Control Governance: Chair or oversee software change control boards and defect management processes. Communicate V&V results to management, including summaries of outcomes and known software anomalies.
- Cross-Functional Partnership: Build strategic alignment with partner organizations, including R&D, Regulatory, Operations, Security, Marketing, and Clinical.
- Risk Management Stewardship: Maintain working knowledge of program hazard analyses, FMEAs, security risk assessments, risk management reports, and post-market lifecycle risk documentation.
- Technical Decision-Making: 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.
- Quality Management System Ownership: Maintain and improve software development, test, and change management procedures, as well as best practices for digital health platform management.
- Manufacturing Software Validation: Demonstrate a deep understanding of validation requirements and processes. Ensure team members support compliant validation of manufacturing and test system software as part of new product development programs.
- Audit and Inspection Readiness: Serve as a senior SME during internal audits and external regulatory inspections. Ensure the team delivers efficient, complete design history files with the elements necessary to demonstrate compliance.
- Stakeholder Communication: Communicate software quality status, risks, and mitigation strategies to senior leadership. Organize and support cross-functional efforts in the event of field actions.
- Continuous Improvement: lead initiatives that strengthen software quality processes, tools, and metrics.
Your Background and Experience
The following represent the minimum qualifications:
- Engineering Degree — BS in Computer Engineering, Computer Science, Electrical Engineering, or related field. Advanced Degree Preferred — MS or higher in engineering or a software-related discipline preferred.
- 8+ years of medical device experience and 3+ years of prior team management experience.
- Medical Device Software and Quality Expertise: 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. Candidates must possess technical capability in software development, preferably C or C#, including the ability to assess code reviews, software defects, verification results, and CAPA conclusions.
- Strategic Quality Planning; Risk Management Leadership; Audit Expertise; Ability to lead strategy and provide technical direction for complex software investigations, CAPAs, quality decisions, and development-related risk assessments.
What We Can Offer You
At LivaNova, you'll help change the trajectory of lives for a new day while working alongside passionate teams dedicated to delivering impactful innovation for patients worldwide.
We offer:
- A role in an innovative medical technology environment that supports professional growth and development.
- Opportunities to collaborate with international partners and cross-functional teams to bring life-changing solutions to patients.
- A culture grounded in Empowered Accountability, Curious Mindset, Constructive Collaboration, and Thoughtful Humility.
- Competitive compensation and an inspiring place to work.
If you're inspired by purpose-driven work, meaningful innovation, and the opportunity to bring New Life in Action every day, we encourage you to apply. We look forward to hearing from you.
