Katalyst CRO
Verification Engineer (Embedded Medical Device)
Katalyst CRO, Burlington, Massachusetts, us, 01805
Overview
Verification Engineer (Embedded Medical Device) role at Katalyst CRO. This position focuses on verification and validation for medical device software/hardware, leading test strategy, planning, execution, and automation efforts to ensure quality and reliability. Responsibilities
Drive verification and validation in software/hardware testing for medical device products. Define and implement comprehensive test strategies and plans to ensure thorough verification, integration, and validation of power system products. Review user requirements, use cases, and system specifications to 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 requirements. Develop the test automation framework for embedded medical devices. Develop, maintain, and extend automated tests 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 and continuous improvement. Collaborate with cross-functional teams to identify and prioritize testing needs, improving test coverage and product reliability. Continuously evaluate and refine testing processes to maintain high 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. Proficient in defining test strategy and test plans for medical device products, embedded systems, mobile apps & web apps; test automation for hardware-software integrated systems. Experience in regulatory compliance testing for medical device standards. Seniority level
Mid-Senior level Employment type
Contract Industries
Pharmaceutical Manufacturing References: Referrals increase your chances of interviewing at Katalyst CRO by 2x. Get notified about new Validation Engineer jobs in Burlington, MA.
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Verification Engineer (Embedded Medical Device) role at Katalyst CRO. This position focuses on verification and validation for medical device software/hardware, leading test strategy, planning, execution, and automation efforts to ensure quality and reliability. Responsibilities
Drive verification and validation in software/hardware testing for medical device products. Define and implement comprehensive test strategies and plans to ensure thorough verification, integration, and validation of power system products. Review user requirements, use cases, and system specifications to 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 requirements. Develop the test automation framework for embedded medical devices. Develop, maintain, and extend automated tests 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 and continuous improvement. Collaborate with cross-functional teams to identify and prioritize testing needs, improving test coverage and product reliability. Continuously evaluate and refine testing processes to maintain high 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. Proficient in defining test strategy and test plans for medical device products, embedded systems, mobile apps & web apps; test automation for hardware-software integrated systems. Experience in regulatory compliance testing for medical device standards. Seniority level
Mid-Senior level Employment type
Contract Industries
Pharmaceutical Manufacturing References: Referrals increase your chances of interviewing at Katalyst CRO by 2x. Get notified about new Validation Engineer jobs in Burlington, MA.
#J-18808-Ljbffr