Demo

Verification Engineer with Medical Domain experience

VTekis Consulting LLP
Palo Alto, CA Full Time
POSTED ON 1/7/2025
AVAILABLE BEFORE 3/6/2025

Job Description

Mandatory skills : Embedded Device Testing,Medical devices, Python,Pytest

Job Summary

We are seeking a meticulous and detail-oriented Medical Device Software Verification Tester to join our team. The successful candidate will be responsible for verifying software used in our medical devices and ensuring compliance with regulatory standards and internal quality requirements. This role involves designing, implementing, and executing test plans and procedures to identify and document software defects.

Key Responsibilities

Test Planning and Design

Develop comprehensive test plans, test cases, and test scripts based on software requirements and design specifications.

Ensure test plans cover all functional and non-functional requirements, including performance, reliability, and security.

Test Execution

Execute manual and automated tests to identify software application defects.

Conduct regression testing to ensure existing functionalities remain unaffected by new changes.

Perform exploratory testing to uncover potential issues not identified by formal test cases.

Documentation and Reporting

Document test results, including detailed descriptions of defects and steps to reproduce them.

Generate and maintain test reports, defect logs, and other documentation required for regulatory compliance.

Communicate test outcomes and defect status to development teams and management.

Collaboration

Work closely with software developers, and systems engineers, to understand software requirements and functionality.

Compliance and Standards

Ensure testing activities comply with relevant regulatory standards (e.g., FDA, ISO 13485, IEC 62304).

Stay updated with industry best practices and evolving regulatory requirements for medical device software.

Qualifications

Education

Bachelor's degree in Computer Science, Software Engineering, Biomedical Engineering, or a related field.

Experience

Minimum of 5 years of experience in software testing, preferably in the medical device industry.

Experience with testing tools and frameworks (e.g., ClearQuest, Jama).

Familiarity with regulatory standards and guidelines for medical devices (e.g., FDA 21 CFR Part 820, ISO 13485, IEC 62304).

Skills and Competencies

Strong understanding of software development and testing methodologies.

Excellent analytical and problem-solving skills.

Attention to detail and a high level of accuracy.

Proficiency in scripting or programming languages (e.g., Python, Java) for test automation.

Good communication and teamwork skills.

Regards,

Mohammed ilyas,

PH - 229-264-4024 or Text - 229-469-1455 or You can share the updated resume at Mohammed@vtekis. com

 

Additional Information

All your information will be kept confidential according to EEO guidelines.

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