Job Title: Product Engineer
Job Description
The Product Engineer leads a defined portion of design history file creation and remediation for several Class I medical devices, ensuring full compliance with applicable regulations and quality management system requirements. This role focuses on translating clinical and technical insights into robust design inputs, optimizing products for safe clinical use, manufacturability, reliability, and cost effectiveness while supporting risk management and project execution activities.
Responsibilities

+ Execute medical device design history file (DHF) activities to ensure compliance with applicable regulations and internal quality management system requirements.

+ Create, update, and remediate design history files for Class I medical devices, covering both devices and associated packaging.

+ Evaluate medical device designs to confirm they meet defined product requirements and are optimized for safe clinical perfo...