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Biogen

Senior Device Quality Engineering Lead

Biogen

Cambridge, MA · Senior

$138,000 – $185,000

Listed on Biogen’s own careers site. You apply with them directly — we never stand between you and the employer.

What this role is

This senior leadership role focuses on ensuring quality and regulatory compliance for medical devices and combination products throughout their lifecycle. It suits experienced quality engineers who are comfortable guiding cross-functional teams, managing supplier relationships, and driving continuous improvement in highly regulated environments.

Our summary, not Biogen’s wording. The full posting is on their site.

Skills this role names

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What they ask for

Required

  • BS in Biomedical/Mechanical Engineering or related technical/scientific discipline
  • At least 7 years of medical device and/or combination product industry experience
  • Extensive knowledge of design control and risk management
  • Strong understanding of medical device regulatory requirements and quality standards
  • Excellent communication and collaboration skills
  • Proven ability to lead cross-functional teams
  • Experience leading continuous improvement initiatives within a Quality Management System
  • Familiarity with medical device supplier and testing partner management

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