Design Assurance Engineer

5 days ago


St Paul, United States ICONMA Full time
  • A Design Assurance Engineer works closely with development/manufacturing/quality engineering to ensure compliance with the quality system.
  • You will work closely with Regulatory Affairs personnel (internal or external) to monitor regulatory compliance.
  • You will monitor quality assurance efforts to ensure that the companys products conform to quality standards. You will partner with research/development and manufacturing engineering during new product start-ups and establishes checkpoints for testing new products and processes.
  • The design assurance engineer is responsible for following established GMP/ISO compliant quality system practices.
  • Ensure companys adherence to the established Quality System and GMP/ISO standards, including ongoing establishment and improvement to the quality system procedures.
  • Lead design assurance activities in support of development for electromechanical systems that utilize microcontroller technology, customized/off the shelf PCBs and software applications. Manage new product Design History Files.
  • Work with Engineering, Marketing, Manufacturing and Regulatory to establish measurable, valid product requirements.
  • Aide in definition of test equipment as required to accomplish quality responsibilities.
  • Develops and documents test plan protocols, test procedures, and test reports.
  • Perform tests according to various protocol requirements.
  • Lead completion of risk management and risk analysis including FMEA.
  • Devise design verification and design validation plans for products based on performance specifications and risk analysis
  • Analyze and communicate conformance to specifications and standards.
  • Conducts technical and statistical investigations concerning compliance to specification and optimization of design relevant to specification.
  • Support completion of in vitro testing including applicable animal studies.
  • Aide in definition of supplier quality specifications, sampling plans, and vendor qualification.
  • Assist in specifications and testing of sterilization methods.
  • Lead system and product continuous improvement teams.
  • Reviews Engineering Change Orders, as required.
  • Perform other duties and responsibilities as assigned by senior management.


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