Senior Software Verification and Validation Engineer - Medical Device

Job Description

Job Description:\n\nMMR Consulting is an engineering and consulting firm specializing in the pharmaceutical and biotechnology industries. Its services include Engineering, Project Management, and Validation.\nMMR Consulting has offices in Canada, USA, and Australia.\nWe are seeking an experienced Senior Software Verification and Validation (V&V) Engineer to support the development, integration, verification, and validation of medical devices, diagnostic systems, laboratory instrumentation, and associated software. The ideal candidate will have strong experience working in a regulated medical device, diagnostic, laboratory, or life sciences environment, with a background in software and system verification and validation.\nThis position will support new product development, software and instrument integration, technology transfer, system-level verification, software validation, and post-launch product support. The engineer will work across hardware, software, systems, laboratory, quality, and engineering functions throughout the product development life cycle.\nThis is a hands-on V&V position, not a role focused solely on writing test documentation.\nThis is a full-time, onsite position in the Rochester, NY area. Candidates must be willing and able to commute to the facility daily.\nApproximately 70% of the role will involve hands-on testing and validation activities, with the remainder involving test planning, requirements review, documentation, data analysis, defect investigation, meetings, and cross-functional engineering activities.\n\nKey Responsibilities\n\nDevelop and execute verification and validation strategies for medical devices, diagnostic systems, laboratory instruments, and associated software.\nDevelop and execute software and system-level test plans, test protocols, test cases, and test procedures.\nPerform verification and validation throughout the medical device/product development life cycle.\nTranslate system, software, and user requirements into measurable verification and validation activities.\nEstablish and maintain requirements traceability between requirements, risk controls, test cases, test execution, and test results.\nPerform hands-on testing of integrated medical device systems, instrumentation, software, and subsystems.\nExecute software validation testing, including functional, system, integration, regression, and negative testing as appropriate.\nEvaluate software/hardware interfaces and system integration to identify unexpected behavior, defects, or performance issues.\nDocument test results, deviations, anomalies, defects, and conclusions in accordance with established quality procedures.\nTroubleshoot failures and unexpected test results and work with engineering and software development teams to identify root causes and corrective actions.\nParticipate in defect investigation, resolution, retesting, and regression testing.\nSupport design verification, subsystem validation, system validation, and post-launch product support.\nGenerate and review requirements, specifications, test procedures, protocols, and validation documentation for completeness and technical accuracy.\nReview the work of other engineers and provide feedback regarding testing quality, documentation, and requirements traceability.\nSupport technology transfer and new product introduction activities.\nWork with multidisciplinary teams consisting of software, systems, electrical, mechanical, laboratory, quality, regulatory, and product development personnel.\nSupport configuration and installation of software and computer systems used in testing.\nParticipate in software/test automation activities where appropriate.\nDevelop or utilize scripts to support automated testing, data collection, test execution, and analysis.\nAdapt quickly to changing project priorities and support multiple projects as required.\n\nSoftware Verification & Validation\nThe successful candidate should have experience with software verification and validation within a regulated product development environment.\nExperience may include:\n\nSoftware requirements verification\nSoftware functional testing\nSystem integration testing\nSystem-level verification\nSoftware validation\nRegression testing\nUser requirements verification\nInterface testing\nInstallation and configuration testing\nAutomated testing\nDefect identification and tracking\nTest script development\nTest execution and results analysis\nRequirements traceability\nRisk-based testing\nSoftware/hardware integration testing\n\nExperience working with software embedded in or supporting medical devices, diagnostic instruments, laboratory systems, or regulated equipment is highly desirable.\nMedical Device V&V\nCandidates should understand the principles of verification and validation within a regulated medical device or diagnostic development environment.\nExperience with the following is highly desirable:\n\nDesign verification\nDesign validation\nSoftware validation\nRequirements management\nTraceability\nRisk-based verification\nTest protocol development\nTest execution\nDefect management\nChange control\nConfiguration management\nDesign controls\nProduct development life cycle processes\nPost-market or post-launch product support\n\nRequired Qualifications\n\nBachelor's degree or higher in Systems Engineering, Software Engineering, Computer Science, Electrical Engineering, Mechanical Engineering, Biomedical Engineering, or a related engineering/science discipline. Equivalent combination of education and directly relevant experience may be considered.\n15+ years of relevant engineering, software V&V, systems V&V, medical device validation, or regulated product development experience; candidates with strong directly applicable experience may be considered with fewer years.\nDemonstrated experience with medical device, diagnostic, laboratory, or other regulated products.\nExperience developing and executing verification and validation testing.\nExperience creating and maintaining requirements traceability.\nExperience working within a structured product development and quality environment.\nExperience troubleshooting complex software/hardware systems.\nStrong understanding of software verification and validation methodologies.\nStrong understanding of system-level verification and validation.\nExperience translating requirements into testable acceptance criteria and test cases.\nStrong technical documentation skills.\nStrong analytical and troubleshooting abilities.\nExperience with software and system integration testing.\nExperience with test automation and/or automated data collection.\nBasic programming or scripting experience using technologies such as:\nPython\nVBA\nC/C++\nOther scripting or programming languages\nExperience configuring and installing computer systems and software used for testing.\nUnderstanding of cybersecurity considerations within medical devices, laboratory systems, or connected equipment is beneficial.\n\nV&V / Quality Systems Experience\nExperience with regulated development processes and quality systems is highly desirable, including familiarity with:\n\nMedical device design controls\nSoftware development life cycle processes\nRequirements management\nRisk management\nConfiguration management\nChange control\nDefect management\nTraceability\nVerification and validation documentation\nQuality management systems\nRegulated product development\n\nDevelopment & Quality Tools\nExperience with one or more of the following is preferred:\n\nJira\nWindchill\nHP ALM / Quality Center\nSerena Business Mashups\nAligned Elements\nMicrosoft Team Foundation Server (TFS)\n\nPreferred Qualifications\n\nExperience with medical device software validation.\nExperience validating software embedded within medical devices or diagnostic instruments.\nExperience with laboratory information systems, diagnostic systems, or laboratory automation.\nExperience with clinical or diagnostic analyzers.\nExperience with automated laboratory analyzers, including VITROS® systems, is a plus.\nExperience with software test automation.\nExperience with Python, VBA, C/C++, or similar programming/scripting languages.\nExperience with assay/instrument integration.\nExperience supporting technology transfer or new product introduction.\nExperience working in a regulated medical device, diagnostics, or life sciences environment.\n\nKey Attributes\nThe successful candidate will be:\n\nHands-on: Comfortable spending significant time executing tests rather than working exclusively on documentation.\nTechnically strong: Able to understand interactions between software, hardware, instrumentation, and systems.\nDetail-oriented: Able to produce accurate, audit-ready V&V documentation and maintain rigorous traceability.\nAnalytical: Able to investigate failures, identify potential root causes, and work with development teams toward resolution.\nAdaptable: Comfortable moving between projects as priorities change.\nCollaborative: Able to work effectively with software, systems, engineering, quality, laboratory, and regulatory teams.\nIndependent: Capable of developing and executing V&V activities with appropriate judgment and minimal supervision.\n\nCompensation starts from 150k/yr based on experience and expertise.\n\nAs part of our recruitment process, we may use technology-assisted tools, including AI-enabled systems, to support application review and candidate evaluation. Hiring decisions are made with human oversight and consideration.\n\nEqual Employment Opportunity and Reasonable Accommodations\nMMR Consulting is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. Our hiring decisions are based on merit, qualifications, and business needs. We are committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please let us know the nature of your request.