Job Description

Job Summary
As a Senior R&D Engineer, you will be instrumental in driving the development of innovative medical products from conception to launch, ensuring adherence to R&D milestones. Your expertise will be crucial in researching and selecting medical-grade materials, identifying and resolving technical challenges, and coordinating extensively with cross-functional teams to manage product development activities. This role requires a strong understanding of FDA Quality System Regulations (21 CFR 820), ISO 13485, and GMP standards, with a focus on design control, risk management, and maintaining comprehensive Design History Files

Responsibilities

  • Meet R&D milestones within the broader product launch schedule.
  • Ensure raw materials meet medical-grade standards consistently.
  • Identify milestone obstacles and develop solutions to well defined technical problems.
  • Conduct research on the structures and properties of materials (fiber...

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