Added
10 days ago
Type
Full time
Salary
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iso 13485 v&v design controls cgmp ind

📋 Description

  • Lead device development as technical lead on delivery systems.
  • Define strategy, design intent, and risk across development to launch.
  • Advise on materials, usability, manufacturability, and trade-offs for cell therapy devices.
  • Lead cross-functional collaboration with Device Development, QA, Regulatory, Supply Chain, and Bayer.
  • Represent device engineering in governance forums and translate tech into risk decisions.
  • Drive design control, DHF integrity, and V&V planning; support global submissions.
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