Design Assurance Engineer

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Design Assurance Engineer

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    Design Assurance Engineer
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Design Assurance Engineer

Our client is an award-winning product development firm who focuses on bringing medical devices from first concept to market launch. We are looking for a Design Assurance Engineer who can ensure the successful integration of quality assurance and regulatory compliance.



  • Plans, executes or directs activities concerned with development, application, and maintenance of quality standards. Reports results to marketing, manufacturing, process engineering, and product design groups
  • Develops and initiates standards and methods for inspection, testing, and evaluation, utilizing knowledge in engineering fields such as electrical, or mechanical
  • Plans, develops, and executes verification testing for products under development as well as performs internal quality and design control audits
  • Performs product and process risk assessment activities, including hazard analysis and design/process failure modes & effects analysis (DFMEA/PFMEA)
  • Assists management in implementing and maintaining a quality system that is compliant with ISO 13485 and FDA quality system regulation requirements
  • Completes component part qualification activities including first articles, cap studies, gage R&R, and implementation of SPC requirements



  • Bachelor’s degree in a scientific/engineering field with 3-7 years of experience in a new product development quality engineering role in the medical, electronics packaging, high reliability, or a related industry with manufacturing & assembly processes
  • High level of competence in statistical techniques, including sampling plans, design of experiments, correlation and regression, analysis of variance, probability, measurement system analyses, gage repeatability and reproducibility, etc.
  • A working understanding of FDA Quality System regulations, EU Active Implantable & Medical Device Directives, ISO 13485 principles
  • Experience in Risk Management Activities and a strong understanding of ISO 14971 as well as experience in Design Verification, Process Validation, and developing user needs and design inputs




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