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Sr. Product Development Engineer

Company

Karwell Technologies

Location

Providence, Rhode Island, United States

Posted

May 12, 2026

Position Overview

                Roles & Responsibilities:    

   Author and maintain design control documentation for combination drug-device and biologic products, including Design History Files (DHF).  

   Ensure compliance with FDA, EU MDR, and internal quality standards throughout the product lifecycle.  

   Support product development and technology transfer from early development through clinical and commercial manufacturing.  

   Translate user needs into functional requirements and design outputs, including support of Human Factors Engineering activities.  

   Develop and support design outputs, specifications, packaging, and verification activities.  

   Perform risk management activities, including authoring DFMEA, UFMEA, and PFMEA.  

   Contribute to requirements management, quality systems, and risk management tools/processes to support development activities.  

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Sr. Product Development Engineer

Position Overview

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