🚀 Verification Engineer (Embedded Medical Device)

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.