What you will be doing
- Verification Planning:
- Develop comprehensive verification plans and test protocols based on system requirements, design specifications, and risk assessments.
- Define test cases, test methods, and acceptance criteria for various levels of testing (unit, integration, system).
- Ensure traceability between test cases and requirements.
- Test Execution and Analysis:
- Execute test protocols on medical device hardware, firmware, and software components.
- Perform functional testing, performance testing, usability testing, and compliance testing.
- Analyze test results, identify discrepancies, and document findings in clear and concise reports.
- Test Automation:
- Develop automated test scripts and frameworks to improve efficiency and repeatability of testing.
- Utilize scripting languages (e.g., Python) and test automation tools to automate test execution and data analysis.
- Documentation and Reporting:
- Generate comprehensive test reports documenting test procedures, results, and conclusions.
- Maintain detailed records of verification activities and contribute to regulatory submissions.
- Contribute to 510k and other regulatory filings.
- Collaboration:
- Collaborate closely with development teams (hardware, firmware, software) to ensure testability of designs and to resolve identified issues.
- Work with cross-functional teams (quality, regulatory, clinical) to ensure compliance with relevant standards and regulations.
What you need
- Bachelor's or Master's degree in Engineering, Computer Science, or a related field.
- 3+ years of experience in verification and validation of medical devices, preferably with experience in wearable technology and/or SaMD.
- Strong understanding of medical device regulations and standards (e.g., ISO 13485, IEC 62304, FDA 21 CFR Part 820).
- Experience with various verification methodologies and techniques.
- Proficiency in scripting languages (e.g., Python) and test automation tools.
- Familiarity with test management tools and defect tracking systems.
- Excellent analytical, problem-solving, and communication skills.
- Ability to work independently and as part of a team.
Top Skills
What We Do
BioIntelliSense is ushering in a new era of continuous health monitoring and clinical intelligence for Remote Patient Monitoring (RPM).
Our medical-grade Data-as-a-Service (DaaS) platform seamlessly captures multi-parameter vital signs, physiological biometrics, and symptomatic events through an effortless patient experience. The FDA-cleared, medical-grade BioButton® wearable device makes remote monitoring and early detection simple. Through the platform’s advanced analytics, clinicians have access to high-resolution patient trending and reporting to enable medical-grade remote care from in-hospital to home.
Learn how BioIntelliSense is redefining remote patient monitoring through medical-grade and cost-effective data services or visit our website at BioIntelliSense.com.