Design Quality Engineer

Designation: Design Quality Engineer

Qualification: Minimum requirement in Mechanical Engineering or a closely related field.


Minimum degree requirement in Mechanical Engineering or a closely related field.

  • Provide support for review of existing documents, assessing gaps, revising documents, creating design engineering rationales to meet EU MDR requirements.
  • Review and approve design documentation including Verification & Validation rationales, risk documents (design and process), standards evaluations, mechanical test protocols and reports.
  • Support risk management activities including planning, design & clinical risk management DFMEA, production risk management PFMEA, and overall risk summary
  • Revise, review and approve verification and validation activities as required.
  • Review and approve any required drawing updates, including design impact assessments.
  • Review and approve any labeling updates, including design impact assessments.
  • Deliverables to be quarterly based on assigned files.
  • Apply statistical methods and design/process excellence tools to support design engineering rationales/memos as required.
  • Provide leadership in all areas of the Quality System, including, but not limited to corrective & preventive actions, product complaints, post market surveillance, nonconforming materials, risk management, and audit support f
  • Provide leadership in the understanding of medical device regulations to other discipline
  • Ability to work in a team setting within Design Quality and cross-functionally is required.
  • Communicate effectively at all levels within Quality, as well as cross functionally with departments such as Product Development, Regulatory, Medical Affairs, Manufacturing, and Marketing.
  • Know and follow all laws and policies that apply to one’s job, and maintain the highest levels of professionalism, ethics and compliance at all times.
  • Report task progress and status on a weekly basis.

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