Verification Validation Engineer

Responsibilities

• Define and execute comprehensive verification approaches for software-controlled electromechanical medical systems at both subsystem and full system levels.
• Author, review, and continuously improve verification protocols and reusable test assets in compliance with applicable regulatory requirements (e.g., FDA, EU MDR).
• Specify, design, and build test setups, fixtures, and benches derived from system requirements to enable both automated and hands-on testing.
• Lead efforts to implement and enhance test automation solutions to increase test coverage, reliability, and efficiency.
• Plan, track, and manage verification timelines, ensuring clear documentation, execution, and communication of results.
• Conduct data-driven analysis including statistical evaluations, sample size rationales, and validation of test methodologies.
• Work in close partnership with systems, software, hardware, and clinical teams to ensure risks are identified, mitigated, and verified appropriately.
• Act as a technical reference point, supporting and guiding less experienced engineers through mentoring and knowledge sharing.
• Align verification activities across multiple projects and teams to ensure harmonized processes and adherence to standards.
• Prepare and maintain verification documentation to support regulatory filings and audits.
• Actively contribute to the ongoing enhancement of organizational V&V processes, tools, and best practices.

Skills and Professional Experience

• At least 5 years of hands-on experience in software and system-level verification, ideally within a regulated medical device environment.
• Strong background in test planning, execution, defect tracking, and investigation.
• Practical experience designing, maintaining, and evolving test benches and test fixtures.
• Excellent analytical and problem-solving abilities, with a structured and methodical working style.
• Demonstrated experience producing high-quality verification and validation documentation in line with FDA and MDR expectations.
• Working knowledge of requirements and test management platforms such as Polarion or DOORS.
• Solid experience with test automation frameworks and scripting languages (e.g., Python, CAPL, VTestStudio).
• Familiarity with CAN bus systems and Vector toolchains.
• Understanding of relevant medical device standards (such as IEC 60601-1, IEC 62304) and regulatory submission pathways (e.g., 510(k)) is advantageous.
• Strong written and verbal communication skills in English; proficiency in German is highly desirable.
• Proactive, self-driven mindset with a strong sense of accountability.
• Commitment to continuous improvement and process optimization.
• Comfortable working autonomously while also contributing effectively within cross-functional teams.

Education

• Master’s degree in medical engineering, software engineering, or a comparable technical discipline.