This is a full-time, onsite position in the Rochester, NY area. Candidates must be willing and able to commute to the facility daily.

We 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.

This 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.

This is a hands-on V&V position, not a role focused solely on writing test documentation.

Approximately 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.

Key Responsibilities

• Develop and execute verification and validation strategies for medical devices, diagnostic systems, laboratory instruments, and associated software.
• Develop and execute software and system-level test plans, test protocols, test cases, and test procedures.
• Perform verification and validation throughout the medical device/product development life cycle.
• Translate system, software, and user requirements into measurable verification and validation activities.
• Establish and maintain requirements traceability between requirements, risk controls, test cases, test execution, and test results.
• Perform hands-on testing of integrated medical device systems, instrumentation, software, and subsystems.
• Execute software validation testing, including functional, system, integration, regression, and negative testing as appropriate.
• Evaluate software/hardware interfaces and system integration to identify unexpected behavior, defects, or performance issues.
• Document test results, deviations, anomalies, defects, and conclusions in accordance with established quality procedures.
• Troubleshoot failures and unexpected test results and work with engineering and software development teams to identify root causes and corrective actions.
• Participate in defect investigation, resolution, retesting, and regression testing.
• Support design verification, subsystem validation, system validation, and post-launch product support.
• Generate and review requirements, specifications, test procedures, protocols, and validation documentation for completeness and technical accuracy.
• Review the work of other engineers and provide feedback regarding testing quality, documentation, and requirements traceability.
• Support technology transfer and new product introduction activities.
• Work with multidisciplinary teams consisting of software, systems, electrical, mechanical, laboratory, quality, regulatory, and product development personnel.
• Support configuration and installation of software and computer systems used in testing.
• Participate in software/test automation activities where appropriate.
• Develop or utilize scripts to support automated testing, data collection, test execution, and analysis.
• Adapt quickly to changing project priorities and support multiple projects as required.

Software Verification & Validation

The successful candidate should have experience with software verification and validation within a regulated product development environment.

Experience may include:

• Software requirements verification
• Software functional testing
• System integration testing
• System-level verification
• Software validation
• Regression testing
• User requirements verification
• Interface testing
• Installation and configuration testing
• Automated testing
• Defect identification and tracking
• Test script development
• Test execution and results analysis
• Requirements traceability
• Risk-based testing
• Software/hardware integration testing

Experience working with software embedded in or supporting medical devices, diagnostic instruments, laboratory systems, or regulated equipment is highly desirable.

Medical Device V&V

Candidates should understand the principles of verification and validation within a regulated medical device or diagnostic development environment.

Experience with the following is highly desirable:

• Design verification
• Design validation
• Software validation
• Requirements management
• Traceability
• Risk-based verification
• Test protocol development
• Test execution
• Defect management
• Change control
• Configuration management
• Design controls
• Product development life cycle processes
• Post-market or post-launch product support

Required Qualifications

• Bachelor'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.
• 15+ 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.
• Demonstrated experience with medical device, diagnostic, laboratory, or other regulated products.
• Experience developing and executing verification and validation testing.
• Experience creating and maintaining requirements traceability.
• Experience working within a structured product development and quality environment.
• Experience troubleshooting complex software/hardware systems.
• Strong understanding of software verification and validation methodologies.
• Strong understanding of system-level verification and validation.
• Experience translating requirements into testable acceptance criteria and test cases.
• Strong technical documentation skills.
• Strong analytical and troubleshooting abilities.
• Experience with software and system integration testing.
• Experience with test automation and/or automated data collection.
• Basic programming or scripting experience using technologies such as:
• Python
• VBA
• C/C++
• Other scripting or programming languages
• Experience configuring and installing computer systems and software used for testing.
• Understanding of cybersecurity considerations within medical devices, laboratory systems, or connected equipment is beneficial.

V&V / Quality Systems Experience

Experience with regulated development processes and quality systems is highly desirable, including familiarity with:

• Medical device design controls
• Software development life cycle processes
• Requirements management
• Risk management
• Configuration management
• Change control
• Defect management
• Traceability
• Verification and validation documentation
• Quality management systems
• Regulated product development

Development & Quality Tools

Experience with one or more of the following is preferred:

• Jira
• Windchill
• HP ALM / Quality Center
• Serena Business Mashups
• Aligned Elements
• Microsoft Team Foundation Server (TFS)

Preferred Qualifications

• Experience with medical device software validation.
• Experience validating software embedded within medical devices or diagnostic instruments.
• Experience with laboratory information systems, diagnostic systems, or laboratory automation.
• Experience with clinical or diagnostic analyzers.
• Experience with automated laboratory analyzers, including VITROS® systems, is a plus.
• Experience with software test automation.
• Experience with Python, VBA, C/C++, or similar programming/scripting languages.
• Experience with assay/instrument integration.
• Experience supporting technology transfer or new product introduction.
• Experience working in a regulated medical device, diagnostics, or life sciences environment.

Key Attributes

The successful candidate will be:

• Hands-on: Comfortable spending significant time executing tests rather than working exclusively on documentation.
• Technically strong: Able to understand interactions between software, hardware, instrumentation, and systems.
• Detail-oriented: Able to produce accurate, audit-ready V&V documentation and maintain rigorous traceability.
• Analytical: Able to investigate failures, identify potential root causes, and work with development teams toward resolution.
• Adaptable: Comfortable moving between projects as priorities change.
• Collaborative: Able to work effectively with software, systems, engineering, quality, laboratory, and regulatory teams.
• Independent: Capable of developing and executing V&V activities with appropriate judgment and minimal supervision.

Compensation starts from 150k/yr based on experience and expertise.

As 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.