Title: Software Verification Engineer (Non-Clinical) - Must have Python, C# -
Location Palo Alto, CA
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 Regards,
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.
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
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, C#) for test automation.
Good communication and teamwork skills
Notes:- All qualified applicants will receive consideration for employment without regard to race, color, religion, religious creed, sex, national origin, ancestry, age, physical or mental disability, medical condition, genetic information, military and veteran status, marital status, pregnancy, gender, gender expression, gender identity, sexual orientation, or any other characteristic protected by local law, regulation, or ordinance.
Benefits: Danta offers a compensation package to all W2 employees that are competitive in the industry. It consists of competitive pay, the option to elect healthcare insurance (Dental, Medical, Vision), Major holidays and Paid sick leave as per state law.
The rate/ Salary range is dependent on numerous factors including Qualification, Experience and Location.
Seniority level
Entry level
Employment type
Contract
Job function
Information Technology
Industries
IT Services and IT Consulting
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