TALENT Software Services

Design Assurance Engineer

Are you an experienced Design Assurance Engineer with a desire to excel? If so, then Talent Software Services may have the job for you! Our client is seeking an experienced Design Assurance Engineer to work at their company in Maple Grove, MN.


Position Summary: Design Assurance Engineer develops, establishes, and maintains quality engineering methodologies, systems, and practices that meet client, customer, and regulatory requirements. Serves as a Quality representative to improve awareness, visibility, and communication on quality initiatives to support departmental, functional, site, divisional and corporate quality goals and priorities. Provides focused quality engineering support within new product development.


Primary Responsibilities/Accountabilities:

  • Identify and implement effective process control systems to support the development, qualification, and ongoing manufacturing of products to meet or exceed internal and external requirements.
  • Acts as an effective leader or team member in supporting quality disciplines, decisions, and practices.
  • Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
  • Support the verification, validation, and usability testing of changes to commercial designs to meet or exceed internal and external requirements
  • Develop Design History File and Design Input / Output documentation (Product Specification, Component Specifications, and Prints)
  • Create and maintain product risk management tools (i.e., Hazard Analysis, Fault Tree, FMEAs)
  • Support test method development and test method validation activities


Qualifications:

  • Bachelor's degree in Engineering discipline or related field of study
  • 2+ years of experience in design assurance, new product development, or related experience in a highly regulated industry
  • Working knowledge of US and International regulations including ISO 13485, ISO 14971, IEC 60601-1, EN 62366, and Quality System Regulations
  • Effectively work and collaborate in a hybrid (onsite plus remote) environment


Preferred:

  • Experience with design risk management (DFMEA, Hazard Analysis, etc) documentation
  • Experience with test method development and/or test method validation

  • Seniority level

    Mid-Senior level
  • Employment type

    Full-time
  • Job function

    Quality Assurance, Design, and Engineering
  • Industries

    Manufacturing

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