Katalyst Healthcares and Life Sciences
Verification Engineer (Embedded Medical Device)
Katalyst Healthcares and Life Sciences, Burlington, Massachusetts, us, 01805
Job Description:
Drive verification and validation in software/hardware testing for medical device products. This role is critical to ensuring the quality and reliability of products by leading test strategy, planning, execution, and automation efforts. The Test Lead will collaborate closely with development teams, product leadership, and other stakeholders to establish best practices, enhance testing efficiency, and improve overall product performance. Responsibilities:
Define and implement comprehensive test strategies, plans to ensure thorough verification, integration, and validation of power system products. Review user requirements, use cases, and system specifications to fully understand project details and align test coverage with product expectations. Plan, develop, and execute system-level, integration, and element-level testing, including new feature, regression, and validation testing to confirm compliance with requirements. Develop the test automation framework for embedded medical device. Develop, maintain, and extend automated test and infrastructure to optimize testing efficiency. Utilize test management and defect tracking tools to ensure effective test execution, traceability, and documentation. Work with continuous engineering and development teams to reproduce, analyze, and resolve customer issues, identifying root causes efficiently. Lead go/no-go release decisions by assessing test results, coverage, and system stability. Guide and mentor test engineers, fostering best practices, continuous improvement, and technical innovation. Collaborate with cross-functional teams to identify and prioritize testing needs, improving overall test coverage and product reliability. Continuously evaluate and refine testing processes and procedures to maintain the highest quality standards. Provide test status reporting, including progress, coverage, and key quality metrics, to stakeholders. Requirements:
Bachelor's or master's degree in, Computer Science, or a related field. 10+ years of experience in software testing as a Lead (R&D environment preferred). 6+ years of experience in embedded medical device test automation. Strong experience in test planning, scheduling, and task estimation for system releases. Proven ability to lead go/no-go decisions for releases based on test results and system performance. Expertise in troubleshooting and root cause analysis to quickly identify system issues. In-depth knowledge of testing methodologies, including Regression, Functional, Performance, Black Box, White Box, and Integration testing. Ability to manage traceability between test plans, test cases, automation sequences, and requirements using test management tools. Strong problem-solving, analytical, and leadership skills, with a focus on driving quality improvements. Experience in international and/or multi-site project development. 10+ years of experience in software testing as a Lead (R&D environment preferred) Proficient in defining test strategy, test plans for medical device products, embedded systems, mobiles apps & web apps Experience in regulatory compliance testing for medical device standard Proficient in test automation for hardware-software integrated systems.
Drive verification and validation in software/hardware testing for medical device products. This role is critical to ensuring the quality and reliability of products by leading test strategy, planning, execution, and automation efforts. The Test Lead will collaborate closely with development teams, product leadership, and other stakeholders to establish best practices, enhance testing efficiency, and improve overall product performance. Responsibilities:
Define and implement comprehensive test strategies, plans to ensure thorough verification, integration, and validation of power system products. Review user requirements, use cases, and system specifications to fully understand project details and align test coverage with product expectations. Plan, develop, and execute system-level, integration, and element-level testing, including new feature, regression, and validation testing to confirm compliance with requirements. Develop the test automation framework for embedded medical device. Develop, maintain, and extend automated test and infrastructure to optimize testing efficiency. Utilize test management and defect tracking tools to ensure effective test execution, traceability, and documentation. Work with continuous engineering and development teams to reproduce, analyze, and resolve customer issues, identifying root causes efficiently. Lead go/no-go release decisions by assessing test results, coverage, and system stability. Guide and mentor test engineers, fostering best practices, continuous improvement, and technical innovation. Collaborate with cross-functional teams to identify and prioritize testing needs, improving overall test coverage and product reliability. Continuously evaluate and refine testing processes and procedures to maintain the highest quality standards. Provide test status reporting, including progress, coverage, and key quality metrics, to stakeholders. Requirements:
Bachelor's or master's degree in, Computer Science, or a related field. 10+ years of experience in software testing as a Lead (R&D environment preferred). 6+ years of experience in embedded medical device test automation. Strong experience in test planning, scheduling, and task estimation for system releases. Proven ability to lead go/no-go decisions for releases based on test results and system performance. Expertise in troubleshooting and root cause analysis to quickly identify system issues. In-depth knowledge of testing methodologies, including Regression, Functional, Performance, Black Box, White Box, and Integration testing. Ability to manage traceability between test plans, test cases, automation sequences, and requirements using test management tools. Strong problem-solving, analytical, and leadership skills, with a focus on driving quality improvements. Experience in international and/or multi-site project development. 10+ years of experience in software testing as a Lead (R&D environment preferred) Proficient in defining test strategy, test plans for medical device products, embedded systems, mobiles apps & web apps Experience in regulatory compliance testing for medical device standard Proficient in test automation for hardware-software integrated systems.