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About the Role

The Monogram Technologies Team at Zimmer Biomet is seeking a detail-oriented Software Validation and Quality Sr Engineer experienced in regulated environments, specializing in software quality review, compliance, and audit readiness, with hands-on capability in validation and testing activities supporting FDA, IEC and ISO standards.

Responsibilities

• Perform software quality review of requirements, design, and deliverables to ensure compliance with FDA, ISO and IEC 62304 standards.
• Ensure adherence to quality system processes and design control requirements across the software development lifecycle.
• Review and approve requirement specifications, test plans, validation protocols, traceability matrices (RTM), and validation reports.
• Support requirements activities by ensuring clarity, completeness, and testability of software requirements.
• Ensure end-to-end traceability between requirements, risk controls, and verification evidence.
• Participate in risk assessments and ensure proper implementation and verification of risk control measures.
• Participate in design reviews, code reviews, and quality reviews of software deliverables.
• Support change management activities, including impact assessment and documentation of software changes.
• Support validation and verification (V&V) activities by developing and executing test plans, test cases, and validation protocols as needed.
• Perform functional, integration, and system-level testing for embedded software and cloud-based systems to support product quality.
• Prepare and review validation documentation including test plans, protocols, reports, and compliance records.
• Support defect investigations to ensure proper root cause analysis and closure.
• Support audit readiness activities and regulatory inspections (FDA, ISO).

Requirements

• Strong understanding of software verification and validation (V&V) principles, including test coverage and objective evidence.
• Experience with validation deliverables including test plans, validation protocols, execution reports, and RTM.
• Familiarity with risk management processes and participation in risk assessments (ISO 14971).
• Experience with change management processes and impact assessment.
• Familiarity with configuration management practices, including version control and release traceability.
• Experience in design reviews, code reviews, and quality reviews of software systems.
• Knowledge of regulatory standards including FDA regulations, IEC 62304, GAMP 5, and 21 CFR Part 11.
• Prior experience working with cross-functional teams including R&D, QA, and Regulatory.

Location

• Austin, Texas

Work Type

• Onsite
• Full-time

Experience Level

• 4 years of relevant experience
• 4+ years of software validation and quality experience

Education Level

• Bachelor's Degree
• Bachelor’s degree in computer science, computer engineering, or a related field.

Benefits

• development opportunities
• robust employee resource groups (ERGs)
• a flexible working environment
• location specific competitive total rewards
• wellness incentives
• a culture of recognition and performance awards

About the Company

• 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.

Equal Opportunity

• EOE