Senior Systems Verification Engineer

Smith & Nephew

6 - 11 years

11 - 15 Lacs

pune

Posted:14 hours ago| Platform:

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Skills Required

computer science medical devices iso 13485 project support agile firmware test cases continuous improvement biomedical robotics

Work Mode

Work from Office

Job Type

Full Time

Job Description

What will you be doing

Lead System Verification Validation: Develop and execute comprehensive test strategies for complex robotic systems, ensuring alignment with product requirements and regulatory standards.
Traceability: Ensure traceability between requirements, test protocols, and results to support regulatory submissions and audits.
Test Planning Execution: Author and manage verification plans, protocols, test cases, traceability matrices, and summary reports.
Equipment Planning: Coordinate with lab management to ensure adequate resources (equipment, personnel, lab space) are available to meet verification timelines.
Defect Management: Identify, report, and track hardware/software defects using tools like JIRA; validate fixes and support root cause analysis. Track defects through lifecycle to closure.
Agile Automation Practices: Contribute to Agile transformation efforts, including test-driven development, BDD, AI-assisted test automation, and backlog management.
Cross-Functional Collaboration: Work closely with systems engineers, software and hardware teams, and global stakeholders to ensure seamless integration and testing.
Regulatory Compliance: Ensure traceability between requirements, test protocols, and results to support FDA, EU MDR, and ISO 13485 submissions.
Project Support: Provide input to technical project plans, risk registers, and design control documentation. Participate in design reviews and FMEAs.
Performance Tracking: Define and monitor KPIs such as test coverage, defect density, on-time sprint delivery, and verification cycle time to drive continuous improvement.

What will you need to be successful

Education : BS in Electrical Engineering, Computer Engineering, Software Engineering, Computer Science, or Biomedical Engineering. Prefer MS or PhD in Electrical Engineering, Computer Engineering, Software Engineering, Computer Science, Biomedical Engineering
Experience : 6+ years of experience in delivering medical device solutions to production with a BS degree (3+ years with a MS degree).
3+ years of experience in medical device verification validation testing.
Tools Experience: Jira, Cockpit, Windchill, or other requirements management, test management, and work management tools.
Outstanding communication, facilitation, and coaching skills
Authoritative knowledge in SAFe, SCRUM, or related Agile frameworks and methodologies
Understanding of the application of ISO 13485, IEC62304 and FDA QS Regulation 21 CFR Part 820
Experience with product development involving hardware, firmware, and software elements
Experience presenting to executive level management on project status.
Physical Demands: Moving lab equipment and systems under test around in lab spaces.

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