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Senior Design Assurance Engineer (Sustaining)

Job description

This job is an excellent opportunity to gain exposure to a Company focused on innovative design & technologies. In this job, you will collaborate with cross functional teams to support sustaining activities within the commercialisation strategy for the entire product lifecycle.

What you will do:

  • Responsible for the design verification and design validation assessment of design changes
  • Lead the risk management activities in sustaining projects, design changes, complaints and CAPAs.
  • Create and maintain design verification and validation plans, protocols, and reports for design changes.
  • Provide sustaining support to project DA engineers on designated projects
  • Support the R&D team for equipment management.
  • Co-ordinate risk management reviews for devices
  • Support the execution of non-clinical studies, in conjunction with R&D teams

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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