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POSTED 02/16/2024

Design Quality Engineer

Location: Minneapolis, MN
Design Quality Engineer – Direct Hire
Brooklyn Park, MN 
Currently looking for a skilled individual to fill a Direct-Hire Design Quality Engineer opening with a company in Brooklyn Park, MN. Interested candidates must have a B.S. Degree in Engineering and a demonstrated use of quality tools and methodologies, strong problem-solving proficiency along with ISO 13485 Lead Auditor training and certification.
Design Quality Engineer Job Description:
  • Own creation and implementation of all design control deliverable
  • Lead on-time Design Verification and Design Validation (and support Process Validation IQ/OQ/PQ/PPQ) planning and execution
  • Actively participate in and contribute to core team and customer facing meetings
  • Drive meaningful translation of User requirements into discrete, objective, measurable, verifiable, and traceable Product requirements
  • Oversee risk management activities throughout the device life cycle - from product concept through post launch
  • Create accurate and repeatable test and inspection methods
  • Support creation and execution of biocompatibility and sterilization qualifications
  • Analyze data and prepare product test reports
  • Oversee content of the Design History File, its completeness and integrity
  • Ensure component specifications are properly defined and evaluated through the creation of supplied component sampling plans, First Article Inspections, and supplier process qualifications
  • Support supplier management activities and external audits
  • Support external audit and certification efforts conducted by customers and regulatory bodies
  • Support manufacturing lines by resolving components issues or other manufacturing barriers in a timely manner
  • Oversee and approve document change requests, non-conformances, deviations, and special work order processes
  • Lead root cause analysis and resolution activities
  • Review and approve equipment specifications and qualification activities
  • Develop/coach/mentor Design Quality Engineering Technicians
Design Quality Engineer Job Requirements:
  • BS degree in Engineering, Science, or technical field with experience in a regulated manufacturing environment
  • Demonstrated use of quality tools and methodologies
  • Strong problem-solving proficiency
  • Ability to manage and prioritize multiple tasks and remain focused on personal objectives
  • High attention to detail and accuracy
  • Proven ability to work effectively independently and on a multi-disciplinary team
  • Good understanding of ISO 13485 and FDA QSR
  • ISO 13485 Lead Auditor training and certification
The starting salary for the Design Quality Engineer position is $90k-$130k annually.