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  5. Design Quality Engineer
Carlsbad, CA
Posted 2 months ago

Job Description

Our chosen candidate will be a “hands on” self-motivated Design Quality Engineer with experience in new product development of medical devices. This position utilizes Quality Engineering tools and methods to support the design control activities for product development and transfer.


  • Responsible for providing quality-engineering support to new product development project from conception through launch
  • Ensure product development activities are conducted in accordance with FDA, QSR, ISO 13485 and internal Quality System requirements
  • Works with cross-functional groups to assist in the development of engineering studies, design verification protocols, stability studies) and validation protocols, ensuring appropriate selection of acceptance criteria and sampling plans
  • Supports process validation by developing or reviewing test protocols and reports.
  • Supports equipment qualifications by reviewing equipment specifications, IQ / OQ reports and unscheduled maintenance reports
  • Work with Engineering and manufacturing on the development and incorporation of Risk Management and compliance to standards during all design phases for new and/or product enhancements
  • Keep up to date on new regulations and standards that affect Risk Management for medical devices
  • Drive continuous improvement efforts, through facilitating, leading, and collaborating with cross-function teams


  • Strong oral and written communication skills
  • Strong understanding of design quality tools, methods, and activities
  • Strong statistical background preferred in reliability/verification, hypothesis testing, sampling, multi-factor analyses
  • Proficient in the use of Microsoft Office Products
  • BS in Engineering or Science discipline with a minimum of 2 years experience


  • Demonstrated knowledge of risk management, statistical methods and new product development
  • Demonstrated knowledge and understanding of FDA and ISO requirements
  • Proven ability to work collaboratively with other functions – Engineering, manufacturing, regulatory, marketing and clinical

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