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Sr. Product Development Engineer

Company

Karwell Technologies

Location

Boston, Massachusetts, United States

Posted

May 06, 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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