Principal Quality Engineer

About the role

The Principal Software Quality Engineer at Zimmer Biomet supports the design, development, and lifecycle support of medical device software, including AI-enabled software. This role collaborates with design and cross-functional teams to ensure compliance with quality, regulatory, and industry standards.

Responsibilities

• Partner with design and cross-functional development teams to support software activities for new product introductions.
• Lead or contribute to software architecture, design, implementation, integration, and maintenance for product development projects.
• Maintain software design documentation and ensure it remains current throughout the product lifecycle.
• Support software changes, enhancements, defect corrections, and sustaining engineering activities for released products.
• Lead software risk management activities, including hazard analysis, risk assessments, and implementation of risk controls.
• Support verification and validation planning, protocol development, execution, and documentation.
• Participate in design reviews and provide technical guidance to ensure robust, compliant, and maintainable software solutions.
• Collaborate with quality, regulatory, systems, and test engineering teams to support compliance with internal procedures and external standards.
• Review and approve technical documentation, including software requirements, architecture and design documents, test protocols, traceability matrices, and change records.
• Ensure software development activities align with design controls, software development lifecycle processes, and applicable regulatory expectations.
• Provide technical leadership for complex troubleshooting, root cause investigations, and continuous improvement initiatives.
• Mentor engineers and serve as a technical leader across multiple projects and product platforms.
• Support audit, inspection, and regulatory submission readiness activities as needed.

Requirements

• Familiarity with AAMI TIR97.
• Knowledge of medical device cybersecurity principles and applicable standards, including ANSI/AAMI/UL 81001-5-1.
• Experience supporting cybersecurity-by-design activities for connected or software-enabled medical devices.

Qualifications

• Bachelor’s degree in Software Engineering, Computer Science, Electrical Engineering, or related technical field; advanced degree preferred.
• 5+ years experience in software engineering, including technical leadership for complex product development programs.
• Strong knowledge of IEC 62304 software development lifecycle processes, software design, and change management.
• Familiarity with FDA software-related guidances and expectations.
• Experience working within a quality management system compliant with ISO 13485.
• Understanding of artificial intelligence applications in medical devices, including associated development and regulatory considerations.
• Strong written and verbal communication skills.
• Proven ability to work effectively across cross-functional teams and influence technical decisions.

Skills

• Experience supporting cybersecurity-by-design activities for connected or software-enabled medical devices.

Benefits

Zimmer Biomet offers a comprehensive benefits package including development opportunities, ERGs, a flexible working environment, competitive total rewards, wellness incentives, and a culture of recognition and performance awards. We strive to create an inclusive environment where every team member feels included, respected, empowered, and recognized.

Pay

$115,000 - $140,000 based on experience

Schedule

Full-time