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.
