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
The Senior Systems Engineer is responsible for leading design control, risk management, and verification & validation (V&V) activities for complex, highly regulated systems, including robotic and algorithm-driven medical devices. This role ensures products meet quality, safety, and regulatory requirements throughout the product lifecycle and supports regulatory submissions and post-market compliance. The role operates as a senior technical authority, partnering closely with Quality, Regulatory Affairs, R&D, Software, Clinical, and Manufacturing teams to deliver compliant, safe, and effective systems.
How You'll Create Impact
Design Controls & QMS Leadership
- Lead and execute design control activities in accordance with 21 CFR Part 820 and ISO 13485
- Ensure traceability between user needs, system requirements, design outputs, verification, and validation
- Provide subject-matter expertise on Quality Management System (QMS) processes and compliance
Risk Management
- Lead risk management activities per ISO 14971, including hazard analysis, risk evaluation, and risk control verification
- Ensure alignment between risk management files, design documentation, labeling, and clinical considerations
- Support risk-based decision-making throughout development and post-market activities
Verification & Validation (V&V)
- Plan, execute, and review verification and validation for complex systems, including software algorithms and system-level behaviors
- Ensure V&V strategies adequately address functional, performance, safety, and usability requirements
- Support integration testing across hardware, software, and algorithmic components
Test Method Validation (TMV)
- Develop, execute, and approve test method validation activities for robotic systems or similar combination products
- Ensure test methods are accurate, repeatable, reproducible, and fit for intended use
- Partner with Quality and Engineering teams to resolve test method deficiencies
Regulatory Submissions & Compliance
- Support and author regulatory submissions, including:
- Letters to File
- Medical Device Reports (MDRs)
- 510(k) submissions
- Provide technical content, system descriptions, and V&V evidence for regulatory filings
Support regulatory interactions, audits, and inspections
What Makes You Stand Out
Quality & Regulatory Systems
- Electronic Quality Management Systems (eQMS) (e.g., TrackWise, ETQ, MasterControl)
- Design history file (DHF), device master record (DMR), and technical file management
Risk & Design Control
- ISO 14971 risk management tools
- Requirements management and traceability tools (e.g., DOORS, Jama, Polarion codeBeamer)
- FMEA/FMECA, fault tree analysis
Verification, Validation & Testing
- System-level test planning and execution
- Test Method Validation (TMV) frameworks
- Algorithm and software V&V methodologies
- Statistical analysis tools (Excel advanced; Minitab preferred)
Regulatory & Standards
- 21 CFR Part 820 (QSR)
- 21 CFR Part 803 (MDR)
- FDA 510(k) requirements and guidance
- ISO 13485, IEC 62304 (software lifecycle preferred), IEC 60601 (if applicable)
Core Competencies
- Strong systems-thinking and technical leadership
- Deep understanding of regulatory and quality frameworks
- Ability to translate complex systems into compliant, testable requirements
- Excellent documentation and inspection readiness discipline
- Strong cross-functional influence and communication skills
Your Background
Preferred Qualifications
- 10+ years total experience in regulated medical device development
- Experience with robotic surgery systems, capital equipment, or SaMD
- Experience supporting FDA inspections and notified body audits
- Experience with algorithm validation, AI/ML systems, or advanced control systems
- Quality or regulatory certifications (CQE, RAC, Six Sigma preferred)
Education
- Bachelor's degree in Systems Engineering, Biomedical Engineering, Electrical Engineering, Mechanical Engineering, or related technical field (or equivalent experience)
- Advanced degree (Master's or Ph.D.) preferred
- 5+ years of experience in systems engineering within FDA-regulated medical device environments
- 5+ years leading design controls and risk management activities
- 5+ years supporting verification & validation of complex systems, including software or algorithms
- Demonstrated experience with regulatory submissions (510(k), MDR, Letters to File)
- Experience with robotic systems or highly regulated combination products strongly preferred
Travel Expectations
EOE/M/F/Vet/Disability
