V&V Engineer

Restore Medical, a leading innovator in medical device development, is looking for a talented Validation & Verification (V&V) Engineer to support and execute all V&V activities. This role demands a strong understanding of V&V processes, hands-on experience and the ability to ensure compliance with regulatory standards.

As part of the R&D team, the V&V Engineer will be responsible for performing detailed verification and validation testing. The position plays a critical role in ensuring that Restore Medical's products meet the highest standards of safety, performance, and regulatory compliance, contributing to the development of innovative healthcare solutions.

Responsibilities

1. Plan, conduct, and manage verification and validation (V&V) testing campaigns to support regulatory submissions Draft protocols and reports in alignment with FDA and ISO guidelines, ensuring compliance with relevant standards. Oversee outsourced testing, including biocompatibility and animal testing
2. Facilitate risk management and design requirements procedures as needed
3. Assist in troubleshooting problems and contributions towards system improvements.
4.  Provide support for production processes

Requirements

1. Education: Mechanical or Bio Medical Engineering
2. Strong proficiency in English (reading, writing, speaking)
3. Experience with medical device testing requirements, including QA procedures and medical device standards
4. Previous experience: At least 3 years in a medical device company, preference for experience with cardiovascular implants and delivery systems
5. Excellent organization skills. Ability to work independently and strong team collaboration skills