Job Description

Description

The Sr. Manufacturing Engineer is responsible for developing, validating, and supporting manufacturing processes for innovative medical devices. Additionally, the engineer supports daily manufacturing operations in a sustaining role, providing technical expertise to resolve issues and maintain production efficiency. This role complies to FDA QSR (21 CFR 820), ISO 13485 requirements and adheres to the Quality Management System (QMS).

  • Provide technical support for day-to-day manufacturing line operations, troubleshooting equipment and process issues.
  • Implement and lead continuous improvement projects to enhance productivity, quality, and cost-effectiveness.
  • Lead process validation activities (IQ/OQ/PQ) in compliance with regulatory requirements.
  • Manage line transfer projects, ensuring smooth transition and qualification of equipment and processes.
  • Apply structured problem-solving methodologies (., 5 Whys, Fishbone, DMAIC)...

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