We are seeking a highly skilled and experienced Senior Systems Verification & Validation (V&V) Engineer to join our team.
The selected candidate will lead and coordinate all V&V activities required to support the release of new and updated medical devices.
This role involves hands-on testing and validation of electromechanical medical devices at the part, sub-system, and system levels, as well as troubleshooting and resolving test issues.
Key Responsibilities
- Lead the planning, coordination, and execution of all Verification and Validation (V&V) activities for medical device projects.
- Develop and review V&V test plans, test cases, and test procedures to ensure comprehensive coverage of requirements.
- Perform system-level testing on electromechanical medical devices such as ventilators, sleep therapy devices, oxygen concentrators, personal wellness devices, and their accessories.
- Utilize test equipment such as TSI Flow Analyzer, Meriam Pressure Analyzer, IMT Analytics Vent Analyzer, Oxigraf Oxygen Analyzer, VI Acoustics Hardware / Software, Cincinnati Sub Zero Environmental Chamber, and Thermotron Environmental Chamber.
- Investigate test issues, document findings, and collaborate with cross-functional teams to resolve technical problems.
- Provide guidance and support to V&V technicians during test execution and troubleshooting activities.
- Generate and maintain verification and validation documentation in accordance with industry standards and company procedures.
- Support regulatory submissions and ensure compliance with relevant standards and guidelines.
Required Qualifications
- Bachelor’s degree in Engineering (e.g., Biomedical, Electrical, Mechanical) or related field.
- 7+ years of experience in systems verification and validation within the medical device industry.
- Extensive experience testing electromechanical systems, preferably medical devices.
- Proficiency in using various test equipment, including flow analyzers, pressure analyzers, and environmental chambers.
- Strong understanding of medical device regulations and standards (e.g., ISO 13485, IEC 60601).
- Excellent problem-solving skills and the ability to work independently as well as part of a team.
- Strong communication skills with the ability to document technical information clearly and concisely.
Preferred Qualifications
- Experience leading V&V activities for complex medical devices.
- Familiarity with FDA regulations and guidance for medical device verification and validation.
- Hands-on experience with automation tools for V&V processes.
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