• Quality Software Validation Manager

    Zimmer Biomet (Austin, TX)


    At Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient’s mobility is enhanced by a Zimmer Biomet product or technology every 8 seconds.

     

    As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life to people around the world. To support our talent team, we focus on development opportunities, robust employee resource groups (ERGs), a flexible working environment, location specific competitive total rewards, wellness incentives and a culture of recognition and performance awards. We are committed to creating an environment where every team member feels included, respected, empowered and recognised.

     

    What You Can Expect

     

    As a **Software Quality Manager** you will be responsible for ensuring the quality, safety, and compliance of software developed for medical device robotic systems, including embedded, cloud-based, and mobile applications. In this role you will provide leadership and technical direction in software validation, verification, regression testing, and cybersecurity to ensure compliance with FDA, ISO 13485, IEC 62304, and ISO 14971 standards.

     

    Monogram's surgeon-guided semi- and fully autonomous robotic technologies are expected to add new and differentiated capabilities to Zimmer Biomet's already broad suite of customer-centric technology solutions. By joining this team you will be taking part in cutting edge technology used to improve patient outcomes and relieve pain for patients across the globe. Excited to join us? Submit your application now.

    How You'll Create Impact

    + You will lead the Software Quality Assurance (SQA) strategy and execution for robotic medical device systems, ensuring compliance with applicable FDA and ISO regulations

    + You will develop and maintain software validation and verification master plans (V&V), test strategies, and detailed protocols for both embedded control software and user-facing applications

    + You will oversee regression testing, penetration testing, and cybersecurity validation, ensuring robust design protection and secure data handling

    + You will ensure requirements traceability, defect tracking, and risk mitigation across the development lifecycle

    + You will ensure validation activities align with design control documentation

    + You will manage a cross-functional team of software quality engineers, validation specialists, and cybersecurity test partners (internal and external)

    + You will support audit readiness and serve as the software quality SME during internal, FDA, and Notified Body audits

    + You will ensure all software quality activities are executed per IEC 62304 (Software Lifecycle Processes) and align with the company’s QMS

    What Makes You Stand Out

    + You have deep understanding of software validation, verification, and risk management for medical devices or robotic systems

    + You have knowledge of relevant regulations and standards: 21 CFR Part 820, ISO 13485, IEC 62304, ISO 14971, and FDA guidance on software validation and cybersecurity

    + You have experience with penetration testing, cybersecurity validation, and data integrity requirements

    + You have strong technical understanding of software development environments including C#, C++, Python, and web technologies

    + You are proficient in software quality tools: JIRA, TestRail, Polarion, Jenkins, and Git

    + You have strong leadership, analytical, and problem-solving skills with proven ability to manage competing priorities

    + You have the ability to drive a culture of quality in agile or hybrid development environments

    + You have experience in software quality assurance, validation, or testing for regulated medical devices

    + You have previous years of leadership or management experience in software quality, validation, or compliance

    + You have experience in robotic systems, control software, or safety-critical applications

     

    Your Background

    Required:

    + You have Bachelor's Degree and 4 years of relevant experience or equivalent experience

    Preferred:

    + Bachelor’s degree in Software Engineering, Computer Science, Electrical Engineering, or related field

    + 2-3 years of previous management experience

     

    Travel Expectations

     

    Up to 25%

     

    EOE/M/F/Vet/Disability