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Job Details

JOB SUMMARY

This senior software automation test engineer, R&D will provide leadership to the verification organization in the development innovative medical technology products and services that improve the quality, effectiveness and efficiency of care. The candidate shall support device verification through rigorous automated testing, ensuring compliance with regulatory standards, and maintaining the highest quality levels. It is a broad role, where collaboration with cross-functional teams, including hardware and system engineering, quality assurance and regulatory affairs will be necessary to deliver robust and reliable software solutions. The candidate will design, develop, review procedures, and test protocols to verify the design per specifications. Candidate will compile data and define changes required in test equipment, procedures, processes, methods, or new testing requirements. This individual will also act as a mentor for junior engineers.

ESSENTIAL DUTIES

• Lead the design, development, and maintenance of automated test scripts, frameworks, and test fixtures to aid in the automation and efficiency of testing processes, ensuring accurate and repeatable test results

• Lead Design, develop, and maintain automated test procedures utilizing both simulated and hardware-in-the-loop environments.

• Execute automated test suites to verify the functionality, performance, and reliability of Class II and III medical devices based on requirements.

• Lead system integration test automation to ensure that test scripts conform to the defined test plans and procedures

• Proficiency in test automation frameworks and tools and experience with scripting languages (e.g., Python, Java)

• Planning the implementation of new tests or enhancing existing automation scripts

• Utilize tracking tools to document and monitor defects, issues, and enhancements throughout the testing lifecycle and generate reports summarizing testing progress, results, and quality metrics

• Create and maintain comprehensive test documentation, including test plans, test cases, test scripts, and test reports.

• Ensure that all test automation activities comply with relevant regulatory standards and guidelines.

• Has technical knowledge of verification and validation process to review and hold design reviews of various test protocols and strategies of product lines.

• Enhances the usage of various test management and requirement management tools in various projects.

• Communicates proactively, openly and cooperatively within the department, team, and with supervisory staff to keep all informed. Prepares clear and timely written and oral status reports, updates, and technical presentations. Exercising sound judgment of what to share, refer, and when to seek assistance, provides timely, accurate, and detailed background data to minimize risks or support problem-resolution or goal achievement.

• Advise, mentor and stay up to date with industry trends, emerging technologies, and best practices in test automation and medical device regulations. Continuously improve test automation processes and methodologies

EDUCATION/EXPERIENCE:

• BS Minimum of 8 years, MS 6+years, OR PhD 4+years

• Experience in medical device or other complex electromechanical system

• Experience with medical device development under FDA Quality Systems Regulations

• Experience of using requirement management tools

• Proficiency in various test automation frameworks and tools, experience with hardware-in-the-loop (HIL) and simulation environments, and the ability to identify the highest value automation opportunities for the system

• Familiarity with version control systems (e.g., Git) and the knowledge to integrate automated testing solutions into CI/CD environments

• Ability to make critical judgments and decisions, to understand root causes of technical problems encountered, and execute thorough completion of documentation associated with work product

• Familiarity with system integration and test method development

• Familiarity with statistical analysis and design of experiments (Minitab, Jmp)

• Experience with scripting languages such as e.g., Python, Java, R, etc.

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