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⏰ Contractor

Product Engineer

Confidential
Location 📍 Caledonia, United States
Posted 📅 June 07, 2026
Work Type ⏰ Contractor

Position Overview

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 ...
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    Job Details

    Employment Type
    Contractor
    📊
    Category
    Engineers
    🏠
    Work Arrangement
    On-site
    📍
    Location
    Caledonia, United States