Senior System Designer

Zimmerbiomet

Bangalore, Karnataka
Permanent
Full-time

2 days ago
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Job DescriptionAt 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 patients 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 ExpectThe 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 ImpactDesign Controls & QMS LeadershipLead 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 complianceRisk ManagementLead 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 activitiesVerification & 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 componentsTest 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 deficienciesWhat Makes You Stand OutTechnologies & ToolsQuality & Regulatory Systems
Electronic Quality Management Systems (eQMS) (e.g., TrackWise, ETQ, MasterControl)
Design history file (DHF), device master record (DMR), and technical file managementRisk & Design Control
ISO 14971 risk management tools
Requirements management and traceability tools (e.g., DOORS, Jama, Polarion codeBeamer)
FMEA/FMECA, fault tree analysisVerification, 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 CompetenciesStrong 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 skillsYour BackgroundPreferred Qualifications10+ 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)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 preferredEducation
Bachelors degree in systems engineering, Biomedical Engineering, Electrical Engineering, Mechanical Engineering, or related technical field (or equivalent experience)
Advanced degree (Masters or Ph.D.) preferredTravel ExpectationsEOE/M/F/Vet/Disability

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