Sr. Software Verification and Validation Engineer

Introduction

Visium Resources has been asked to identify qualified candidates for this Senior Software Verification and Validation Engineer position. This position is a direct hire opportunity which is expected to be on-site at clients facility in Rochester, New York. Laboratory / Testing Commitment: Approximately 70% hands-on testing and validation activities.

Summary

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 position will involve hands-on testing, system/software validation, troubleshooting, and laboratory activities .

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

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

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

Required Qualifications

Education

• 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.

Experience

• Typically 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.

Technical Skills

• 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.

Work Environment

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

Ideal Candidate Profile

The ideal candidate is a senior-level Medical Device V&V Engineer, Software Validation Engineer, Software V&V Engineer, Systems V&V Engineer, or Medical Device Systems Engineer who has experience validating software and integrated systems within a regulated product development environment.

Strong candidates may come from backgrounds including:

• Medical devices
• Diagnostic instrumentation
• Clinical laboratory systems
• Laboratory automation
• Embedded medical device software
• Regulated electromechanical systems

Candidates should be able to demonstrate hands-on experience developing and executing V&V testing-not simply writing test cases or managing V&V documentation.