Senior Design Assurance Engineer

Job description

This job is an excellent opportunity to gain exposure to a Company focused on innovative design & technologies. In this job, you will lead the Design Control, Risk Management and associated activities, for existing & new product developments. 

What you will do:

  • Provide Design Assurance guidance to R&D teams
  • Lead risk management activities for design changes & projects
  • Create, develop and validate test methods
  • Create & maintain design verification and validation plans, protocols and reports
  • Support the execution of non-clinical studies, in conjunction with R&D team
  • Coach & mentor junior design assurance engineers

What you will have:

  • Level 8 Bachelor degree in Engineering, Science or related discipline
  • 5 years’ relevant experience in the medical device or pharmaceutical industry
  • Strong understanding of ISO13485, ISO14971 and FDA QSRs
  • Highly analytical with sound understanding of statistics, validation and physical testing

What you will receive:

  • Competitive Salary & Comprehensive Benefits Package

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