My client is an exciting MedTech company focusing on innovative point-of-care diagnostics currently approaching FDA approval on several key product lines.
You will play a critical part in ensuring the functionality, performance, and regulatory compliance of my client's flagship product. You will work closely with design, firmware, and quality teams to test and validate our product, helping to bring it from development through to clinical trials and eventual FDA approval.
Key Responsibilities:
- Collaborate with design engineers, firmware, and quality teams to create comprehensive test plans.
- Develop and execute test protocols for hardware, firmware, and software components.
- Ensure compliance with FDA 510k regulations and ISO standards.
- Define, document, and maintain QMS processes related to V&V.
- Identify and address testing bottlenecks, ensuring smooth product progression through clinical and regulatory phases.
- Provide regular updates on V&V progress and potential risks.
Qualifications:
- Bachelor’s degree in Electrical Engineering, Mechanical Engineering, or a related field.
- 3+ years of experience in verification and validation for medical devices or similar industries.
- Strong understanding of FDA 510k regulatory requirements.
- Ability to work cross-functionally and manage multiple tasks under tight timelines.
- Excellent attention to detail and problem-solving skills.
