Description

You will manage system and software verification processes for complex medical product testing.

This role is on-site.

Responsibilities

• Analyze functional requirements to develop comprehensive system and software verification plans.
• Execute functional, integration, regression, and formal testing in compliance with established procedures.
• Manage the traceability matrix linking user stories, requirements, and test cases.
• Oversee offshore team activities, including task allocation, test environment setup, and monitoring of test metrics.
• Document defects and generate detailed test summary and coverage reports.

Required Skills

• 7+ years of experience in functional testing, quality assurance, and medical device testing.
• Proven expertise in Computer System Validation and Tool Validation.
• Deep knowledge of medical standards including ISO 13485, ISO 14971, and IEC 62304.
• Experience with test management, including development of test metrics and coverage reports.
• Proficiency in drafting system and functional test cases based on specifications.
• Hands-on experience with JIRA, JAMA, or Bugzilla for requirements and defect management.
• Strong understanding of testing within Agile methodologies.

Preferred Skills

• Bachelor’s degree in Computer Science, Information Systems, Biomedical Engineering, or a related field.

Key Skills

Education

Bachelor's Degree