Validation & Verification (V&V) Engineer – Medical Imaging

Quest Global; München; Vor Ort; EUR 55.000 - 85.000; Vollzeit

Benefits dieser Stelle

Salary range 55k–85k EUR gross/year

Zusammenfassung

Quest Global in Bayern, Germany, seeks a Software Verification & Validation engineer for medical imaging products. You will design and execute manual V&V activities, develop protocols, and ensure compliance with IEC 62304, ISO 13485, ISO 14971, FDA MDR, and related standards while collaborating with Regulatory, Clinical, and Development teams.

Requirements include a Bachelor’s or Master’s in a related field, 6–8 years in V&V, strong testing methods, defect management, and experience with

Qualifikationen

• Bachelor's or Master's degree in Computer Science, Biomedical Engineering, Electronics, or related engineering discipline.
• 6-8 years of experience in software Verification & Validation (Manual Testing).
• Experience developing verification protocols, validation protocols, test plans, test cases, and test reports.
• Strong understanding of software testing methodologies and the Software Development Life Cycle (SDLC).
• Experience with defect tracking and test management tools such as Jira, DevOps, or equivalent.
• Excellent analytical, documentation, and problem-solving skills.
• Basic understanding of DevOps concepts and software deployment workflows.
• Strong communication and cross-functional collaboration skills.
• Knowledge of and experience working within medical device quality and regulatory frameworks, including IEC 62304, ISO 13485, ISO 14971, FDA 21 CFR Part 820/QMSR, and EU MDR.

Aufgaben

• Plan, design, and execute manual verification and validation activities for medical imaging software applications.
• Develop, review, and maintain verification and validation protocols, test plans, test cases, and test reports.
• Validate software features against functional, system, and user requirements.
• Perform system, functional, integration, regression, and usability testing.
• Identify, document, and track software defects through resolution using defect management tools.
• Ensure all V&V documentation complies with applicable medical device software development and quality management standards.
• Collaborate with Software Development, Product Management, Clinical Specialists, and Regulatory teams throughout the software development lifecycle.
• Review software requirements and design documents to ensure completeness and testability.
• Participate in risk-based testing and traceability activities to ensure comprehensive test coverage.
• Support release readiness by providing verification evidence and quality documentation.
• Gain exposure to DevOps concepts and support validation activities within CI/CD environments where applicable.

Kenntnisse

Manual Verification & Validation

Test Protocol Development

Defect Tracking

Requirements Traceability

Risk-Based Testing

Regulatory Knowledge

Communication & Collaboration

SDLC Knowledge

Ausbildung

Bachelor's or Master's degree in Computer Science, Biomedical Engineering, Electronics, or related engineering

Tools

Jira

DevOps

Rally

AWS

Jobbeschreibung

Job Requirements

At Quest Global, it’s not just what we do but how and why we do it that makes us different. With over 25 years as an engineering services provider, we believe in the power of doing things differently to make the impossible possible. Our people are driven by the desire to make the world a better place—to make a positive difference that contributes to a brighter future. We bring together technologies and industries, alongside the contributions of diverse individuals who are empowered by an intentional workplace culture, to solve problems better and faster.

Job Requirements

At Quest Global, it’s not just what we do but how and why we do it that makes us different. With over 25 years as an engineering services provider, we believe in the power of doing things differently to make the impossible possible. Our people are driven by the desire to make the world a better place—to make a positive difference that contributes to a brighter future. We bring together technologies and industries, alongside the contributions of diverse individuals who are empowered by an intentional workplace culture, to solve problems better and faster.

Key Responsibilities

• Plan, design, and execute manual verification and validation activities for medical imaging software applications.
• Develop, review, and maintain verification and validation protocols, test plans, test cases, and test reports.
• Validate software features against functional, system, and user requirements.
• Perform system, functional, integration, regression, and usability testing.
• Identify, document, and track software defects through resolution using defect management tools.
• Ensure all V&V documentation complies with applicable medical device software development and quality management standards.
• Collaborate with Software Development, Product Management, Clinical Specialists, and Regulatory teams throughout the software development lifecycle.
• Review software requirements and design documents to ensure completeness and testability.
• Participate in risk-based testing and traceability activities to ensure comprehensive test coverage.
• Support release readiness by providing verification evidence and quality documentation.
• Gain exposure to DevOps concepts and support validation activities within CI/CD environments where applicable.

We are known for our extraordinary people who make the impossible possible every day. Questians are driven by hunger, humility, and aspiration. We believe that our company culture is the key to our ability to make a true difference in every industry we reach. Our teams regularly invest time and dedicated effort into internal culture work, ensuring that all voices are heard.

We wholeheartedly believe in the diversity of thought that comes with fostering a culture rooted in respect, where everyone belongs, is valued, and feels inspired to share their ideas. We know embracing our unique differences makes us better, and that solving the worlds hardest engineering problems requires diverse ideas, perspectives, and backgrounds. We shine the brightest when we tap into the many dimensions that thrive across over 21,000 difference-makers in our workplace.

Qualifications

Work Experience

• Bachelor's or Master's degree in Computer Science, Biomedical Engineering, Electronics, or a related engineering discipline.
• 6-8 years of experience in software Verification & Validation (Manual Testing).
• Experience developing verification protocols, validation protocols, test plans, test cases, and test reports.
• Strong understanding of software testing methodologies and the Software Development Life Cycle (SDLC).
• Experience with defect tracking and test management tools such as Jira, DevOps, or equivalent.
• Excellent analytical, documentation, and problem-solving skills.
• Basic understanding of DevOps concepts and software deployment workflows.
• Strong communication and cross-functional collaboration skills.
• Knowledge of and experience working within medical device quality and regulatory frameworks, including IEC 62304 (Medical Device Software Lifecycle Processes), ISO 13485 (Quality Management Systems), ISO 14971 (Risk Management), FDA 21 CFR Part 820/QMSR, and EU Medical Device Regulation (MDR).
• Experience applying regulatory requirements and industry best practices throughout the software verification and validation lifecycle for medical imaging products.
• Familiarity with compliance documentation, traceability, risk management, and software validation activities required for regulated medical device environments.
• Understanding of global medical device standards and regulatory expectations governing the development, testing, and release of healthcare software solutions.
• German language proficiency

Preferred Qualifications

• Experience in the Medical Imaging or Healthcare Software domain.
• Knowledge of DICOM, PACS, HL7, or FHIR standards.
• Experience preparing validation documentation in accordance with organizational and medical device quality processes.
• Exposure to regulated software development environments and design verification activities.

Technical Skills

• Manual Verification & Validation Testing
• Test Protocol, Test Plan, Test Case & Test Report Authoring
• Functional, System, Integration & Regression Testing
• Defect Tracking and Test Management
• Requirements Traceability
• Risk-Based Testing
• Medical Device Documentation
• Jira/Rally
• Basic AWS Knowledge
• Basic DevOps Knowledge
• Medical Imaging Domain Knowledge (Preferred)

Benefits

• based on seniority & experience, our budget for the role is between 55k - 85k Euro gross/year