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Senior Software Verification and Validation Engineer

Visium Resources

Job Location:

Rochester, NH - USA

Monthly Salary: Not provided by the employer

Posted: 29 September 2026 (19 hours ago)

Application Deadline: 27 December 2026

Vacancies: 1 Vacancy

Job Summary

Details:

Introduction
Visium Resources has been asked to identify qualified candidates for this Senior Software Verification and Validation Engineerposition. 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 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

Details:

Required Qualifications

Education

Bachelors 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.

Visium Resources is an award-winning employment firm with a mission to match talented individuals with highly successful organizations. At Visium our companys success is based on your success. When you work with us you are never just a number. You are our most important asset. Here you will know us by name through our regular visits to client sites and even occasional luncheons. We will always be there when you need assistance and will always go the extra mile to ensure that you are as successful as possible. Whether youre looking for contract contract-to-hire or permanent opportunities we firmly believe there is no employment agency that will work harder for you than Visium.

Visium Resources is an equal opportunity employer and values diversity. All employment is decided based on qualifications merit and business need.

Required Experience:

Senior IC

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