Zimmer Biomet is looking to ensure the quality, safety, and compliance of software developed for medical device robotic systems, including embedded, cloud-based, and mobile applications.
Requirements
- Deep understanding of software validation, verification, and risk management for medical devices or robotic systems.
- Knowledge of relevant regulations and standards: 21 CFR Part 820, ISO 13485, IEC 62304, ISO 14971, and FDA guidance on software validation and cybersecurity.
- Experience with penetration testing, cybersecurity validation, and data integrity requirements.
- Strong technical understanding of software development environments including C-Sharp, C++, Python, and web technologies.
- Proficiency in software quality tools: JIRA, TestRail, Polarion, Jenkins, and Git.
- Experience in robotic systems, control software, or safety-critical applications is highly desirable.
Responsibilities
- Lead the Software Quality Assurance (SQA) strategy and execution for robotic medical device systems, ensuring compliance with applicable FDA and ISO regulations.
- 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.
- Oversee regression testing, penetration testing, and cybersecurity validation, ensuring robust design protection and secure data handling.
- Collaborate with Software Engineering and Systems teams to ensure requirements traceability, defect tracking, and risk mitigation across the development lifecycle.
- Ensure validation activities align with design control documentation (e.g., Design History File, Risk Management File, and Verification & Validation Reports).
- Drive the integration of automated testing frameworks for continuous integration and delivery pipelines, supporting both development efficiency and compliance evidence generation.
- Partner with IT Security and Cyber teams to define and execute penetration and vulnerability assessments.
Other
- Manage a cross-functional team of software quality engineers, validation specialists, and cybersecurity test partners (internal and external).
- Represent Quality during design reviews, risk assessments, and change control boards.
- Support audit readiness and serve as the software quality SME during internal, FDA, and Notified Body audits.
- Lead continuous improvement in software quality systems, including procedures for software validation, configuration management, and defect tracking.
- Strong leadership, analytical, and problem-solving skills with proven ability to manage competing priorities.
- Excellent communication, documentation, and collaboration skills, with the ability to lead discussions across technical and non-technical teams.
- Demonstrated ability to drive a culture of quality in agile or hybrid development environments.
- Minimum 8 years of experience in software quality assurance, validation, or testing for regulated medical devices.
- Minimum 2–3 years of leadership or management experience in software quality, validation, or compliance.
- Up to 25% Travel Expectations
