My client is an exciting MedTech company developing an innovative cardiovascular product that helps assess patients at the point of emergency, dramatically improving outcomes.
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.
- 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:
- 3+ years of experience in testing for medical devices or similar industries.
- Experience testing embedded systems.
- Bachelor’s degree in Electrical Engineering, Mechanical Engineering, or a related field.
- Strong understanding of FDA 510k regulatory requirements.
- Ability to work cross-functionally and manage multiple tasks under tight timelines.
