Katalyst CRO

Design Quality Engineer

Marlborough, MA

3 months ago
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Summary

Responsibilities

  • Ensure design verification and validation activities meet regulatory requirements.
  • Support new product development and sustaining engineering projects, ensuring compliance with FDA QSR, ISO 13485, and ISO 14971.
  • Collaborate with R&D, Regulatory, and Quality teams to manage design risk and test method validation.
  • Lead Health Risk Assessments for market products and evaluate design change impacts.
  • Assess and document design inputs, usability, reliability, and biocompatibility standards.

Requirements:

  • Bachelor's degree in a technical field.
  • 2-5 years experience in medical devices or regulated industry.
  • Strong knowledge of design control, risk management, and regulatory requirements (FDA, ISO 13485, ISO 14971).
  • Experience with verification & validation, root cause failure analysis, and statistical methods.
  • Ability to work cross-functionally and manage compliance documentation.
  • Experience with test method validation, DOE, and failure analysis.
  • Familiarity with sterilization, packaging, and software validation.

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