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Sustaining Engineering Manager

Intellectt Inc

Libertyville · On-site Contract Lead 1mo ago

About the role

About

We are seeking an experienced Sustaining Engineering Manager to support post-launch medical device products and sustaining activities within a manufacturing environment.

Key Responsibilities

  • Manage sustaining and post-launch projects for medical device products
  • Coordinate with Engineering, Manufacturing, Quality, Supply Chain, and Regulatory teams
  • Support product improvements, issue resolution, change control, and process optimization
  • Track project timelines, risks, deliverables, and stakeholder communication
  • Ensure compliance with FDA, GMP, and quality system requirements
  • Drive continuous improvement initiatives within manufacturing operations

Qualifications

  • Bachelor’s degree in Engineering, Life Sciences, or related field
  • 5+ years of project management experience in medical device manufacturing
  • Experience with sustaining engineering and product lifecycle support
  • Strong knowledge of manufacturing processes and regulated environments
  • Excellent leadership, communication, and organizational skills

Skills

FDAGMP

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