Medical Device Verification and Validation Engineer

The focus will be on mechanical and medical device testing, as well as V&V protocols through simulated use studies in collaboration with surgeons.

Responsibilities

Design Verification & Validation :

• Plan, execute, and document design verification and validation (V&V) activities to support product development while ensuring compliance with internal standards and regulatory requirements.

Technical Support :

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

Regulatory Compliance :

• Ensure product development and V&V activities align with relevant regulatory standards (e.g., FDA QSRs, ISO 13485, ISO 14971). Assist with documentation and submission efforts as needed.

Design Control :

• Contribute to and support the design control process, including documentation, reviews, traceability, and compliance with quality management systems.

Sustaining Engineering :

• Assist in post-market product support by conducting root cause analysis and engineering evaluations to resolve product issues or implement improvements.

Quality and Compliance Authority :

• Hold any product or QA / RA documentation from shipment or further processing in cases of potential non-compliance and escalate concerns to management promptly.

Qualifications :

3+ years of relevant experience as a Verification & Validation Engineer in a dynamic medical device environment, ideally focusing on specialty medical practices.

Project Management Skills : Strong planning and organizational skills, with an ability to manage schedules effectively and meet deadlines. Proactive and determined in driving tasks to completion.

Technical Writing : Strong technical writing skills with a keen eye for detail ensuring clarity and accuracy.

Standards-Based Testing : Proven experience in performing testing in accordance with industry standards, such as ISO or ASTM.

Communication & Teamwork : Effective communicator who collaborates well with engineers, surgeons, clinicians, and sales / distribution teams.

Cross-Functional Knowledge : Solid understanding of how various departments within a medical device company operate, including engineering, manufacturing, R&D, product marketing, clinical, regulatory, and quality.

Test Fixture Design : Experience in designing and building mechanical test fixtures utilizing tools such as mills, lathes, or 3D printers.