V&V Consultant
Software Verification and Validation Engineer
12-Month Onsite Contract - Finland
As a Software Verification and Validation Engineer, you will play a critical role in ensuring that complex medical systems and instruments meet their intended functionality, safety, and performance standards. This role is based onsite in Finland and involves close collaboration with cross-functional teams to verify both software and hardware components of medical devices.
Key Responsibilities
Planning and Performing Verification
- Develop and execute comprehensive verification plans, protocols, and reports for software and instrument systems.
- Ensure all verification activities comply with relevant regulatory standards (e.g., FDA, ISO 13485, IEC 62304).
- Conduct risk analysis and maintain up-to-date risk management documentation.
Software and Instrument Testing
- Design and implement test cases and procedures based on software and system requirements.
- Perform both manual and automated testing of embedded software and instrument interfaces.
- Validate integration between software and hardware components, ensuring system-level functionality.
Data Analysis and Reporting
- Analyse test results and document verification outcomes.
- Identify, log, and track defects or non-conformities; collaborate with development teams for resolution.
- Provide clear and concise reports to stakeholders.
Collaboration and Communication
- Work closely with software developers, systems engineers, and quality assurance teams.
- Mentor junior engineers and contribute to continuous improvement of verification processes.
- Communicate progress, risks, and issues effectively across teams.
Documentation and Traceability
- Maintain detailed records of all verification activities.
- Ensure full traceability from requirements through to verification and risk management documentation.
Qualifications
Education
- Bachelor's or Master's degree in Software Engineering, Biomedical Engineering, Electrical Engineering, or a related field.
Experience
- 5-10 years of experience in software/system verification, preferably in the medical device industry.
- Hands-on experience with software and instrument testing in regulated environments.
Skills and Competencies
- Strong analytical and troubleshooting skills for both software and hardware.
- Proficiency in verification tools and test automation frameworks.
- Familiarity with regulatory standards (FDA, ISO 13485, IEC 62304).
- Excellent communication and documentation skills.
- Ability to work effectively in a collaborative, multidisciplinary team environment.
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