Medical Device Verification and Validation Engineer

Join our dynamic team and play a crucial role in enhancing patient care through innovative medical devices! As a Verification and Validation Engineer, you will collaborate closely with surgeons to conduct mechanical testing and develop validation protocols, ensuring our products exceed expectations.

Key Responsibilities :

• Design Verification & Validation : Strategically plan, execute, and meticulously document design verification and validation (V&V) activities that support product development while ensuring strict adherence to internal and regulatory guidelines.

Technical Support :

• Provide essential engineering support for mechanical instruments and systems throughout their lifecycle, addressing all technical aspects of the product.

Regulatory Compliance :

• Ensure that product development processes and V&V activities align with regulatory standards (e.g., FDA QSRs, ISO 13485, ISO 14971), and assist with the preparation and submission of relevant documentation.

Design Control :

• Engage actively in the design control process, ensuring compliance with documentation, reviews, traceability, and quality management systems.

Sustaining Engineering :

• Support post-market activities including root cause analysis and engineering evaluations, driving improvements and resolving product issues effectively.

Quality and Compliance Authority :

• Possess the authority to prevent shipment or further processing of products or QA / RA documentation in cases of potential non-compliance, escalating any concerns to management as necessary.

Qualifications :

We are seeking candidates with a minimum of 3 years of recent experience as a Verification & Validation Engineer in a thriving medical device company, particularly within specialty medical practices.

Desirable Skills :

• Project Management : Showcase strong organizational skills, an ability to manage schedules effectively, and a proactive approach to completing tasks.
• Technical Writing : Exhibit clear and precise technical writing abilities with great attention to detail.
• Testing Standards : Demonstrated experience in conducting tests according to industry standards such as ISO or ASTM.
• Communication & Teamwork : Strong communicator, fostering collaborative relationships with engineers, surgeons, clinicians, and sales / distribution teams.
• Cross-Functional Knowledge : Solid understanding of interactions across various disciplines within a medical device organization, including engineering, manufacturing, R&D, product marketing, clinical, regulatory, and quality departments.
• Test Fixture Design : Proficient in designing and constructing mechanical test fixtures using tools like mills, lathes, or 3D printers.