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About the Role

MMR Consulting is 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. This hands-on role requires strong experience in regulated environments and involves approximately 70% hands-on testing and validation.

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.

Requirements

Experience with software verification and validation within a regulated product development environment.
Experience with software requirements verification.
Experience with software functional testing.
Experience with system integration testing.
Experience with system-level verification.
Experience with software validation.
Experience with regression testing.
Experience with user requirements verification.
Experience with interface testing.
Experience with installation and configuration testing.
Experience with automated testing.
Experience with defect identification and tracking.
Experience with test script development.
Experience with test execution and results analysis.
Experience with requirements traceability.
Experience with risk-based testing.
Experience with software/hardware integration testing.
Understand the principles of verification and validation within a regulated medical device or diagnostic development environment.
Experience with design verification.
Experience with design validation.
Experience with software validation.
Experience with requirements management.
Experience with traceability.
Experience with risk-based verification.
Experience with test protocol development.
Experience with test execution.
Experience with defect management.
Experience with change control.
Experience with configuration management.
Experience with design controls.
Experience with product development life cycle processes.
Experience with post-market or post-launch product support.
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++, or other scripting or programming languages.
Experience configuring and installing computer systems and software used for testing.
Experience with regulated development processes and quality systems.
Familiarity with medical device design controls.
Familiarity with software development life cycle processes.
Familiarity with requirements management.
Familiarity with risk management.
Familiarity with configuration management.
Familiarity with change control.
Familiarity with defect management.
Familiarity with traceability.
Familiarity with verification and validation documentation.
Familiarity with quality management systems.
Familiarity with regulated product development.
Experience with Jira.
Experience with Windchill.
Experience with HP ALM / Quality Center.
Experience with Serena Business Mashups.
Experience with Aligned Elements.
Experience with Microsoft Team Foundation Server (TFS).
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.
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.

Skills

Software Verification and Validation (V&V)
Medical Device Development
Diagnostic Systems
Laboratory Instrumentation
Software Validation
System Integration
Test Planning
Requirements Review
Documentation
Data Analysis
Defect Investigation
Cross-functional Engineering
Hands-on Testing
Requirements Traceability
Software/Hardware Interface Evaluation
Failure Troubleshooting
Root Cause Analysis
Corrective Actions
Defect Management
Retesting
Regression Testing
Design Verification
Subsystem Validation
System Validation
Post-launch Product Support
Technical Documentation
Technology Transfer
New Product Introduction
Multidisciplinary Teamwork
Software/Test Automation
Scripting (Python, VBA, C/C++)
Computer System Configuration
Cybersecurity Considerations
Design Controls
Product Development Life Cycle Processes
Risk Management
Configuration Management
Change Control
Quality Management Systems
Regulated Product Development
Jira
Windchill
HP ALM / Quality Center
Serena Business Mashups
Aligned Elements
Microsoft Team Foundation Server (TFS)
Laboratory Information Systems
Diagnostic Analyzers
Automated Laboratory Analyzers
VITROS® systems
Assay/Instrument Integration

Location

Rochester, NY area

Work Type

Full-time
Onsite

Experience Level

Senior
15+ years of relevant engineering, software V&V, systems V&V, medical device validation, or regulated product development experience

Education Level

Bachelor's degree or higher in Systems Engineering, Software Engineering, Computer Science, Electrical Engineering, Mechanical Engineering, Biomedical Engineering, or a related engineering/science discipline.

Salary/Compensations

Starts from 150k/yr based on experience and expertise.

About the Company

MMR Consulting is an engineering and consulting firm specializing in the pharmaceutical and biotechnology industries.
Its services include Engineering, Project Management, and Validation.
MMR Consulting has offices in Canada, USA, and Australia.

Equal Opportunity

MMR 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.