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Design Quality Engineer II
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Intellectt, Inc
Maple Grove, MN (In Person)
Full-Time
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Job Description
Design Quality Engineer II at Intellectt, Inc Design Quality Engineer II at Intellectt, Inc in Maple Grove, Minnesota Posted in 2 days ago.
Create and maintain Design Inputs, Design Outputs, Design Reviews, Verification & Validation documents, and Traceability Matrice s.
Update and maintain risk management documentation, including DFMEA, Hazard Analysis, and Risk Control s.
Ensure traceability between design requirements, risk controls, verification, and validation activitie s.
Partner with R D, Manufacturing, Regulatory Affairs, and Document Control team s.
Support audit and inspection readiness activitie s.
Track remediation progress and drive assigned deliverables to completio n. Required Qualificati onsBachelor's degree in Engineering or related fie ld.3+ years of medical device industry experien ce.
Strong knowledge of Design Controls, DHF documentation, and Quality Syste ms.
Experience with risk management documentation (DFMEA, Hazard Analysis, Risk Control s).Familiarity with product lifecycle documentation and engineering change process es.
Strong technical writing, documentation, and problem-solving skil ls. Preferred Qualificat ionsExperience with DHF remediation proje cts.
Knowledge of FDA Quality System Regulations and medical device standa rds.
Experience supporting audits and regulatory inspecti ons.
Type:
full-timeJob Description:
Jon Title :
Design Quality Engineer III Location:
Maple Grove, MN (Onsite)Employment Type:
Long Term Contract Position Summar ySeeking a Design Quality Engineer III to support Design History File (DHF) remediation and design control activities for sustaining medical device products. The role focuses on ensuring design documentation is complete, compliant, traceable, and audit-ready while collaborating with cross-functional teams . Key Responsibiliti esSupport DHF remediation, gap assessments, and documentation update s.Create and maintain Design Inputs, Design Outputs, Design Reviews, Verification & Validation documents, and Traceability Matrice s.
Update and maintain risk management documentation, including DFMEA, Hazard Analysis, and Risk Control s.
Ensure traceability between design requirements, risk controls, verification, and validation activitie s.
Partner with R D, Manufacturing, Regulatory Affairs, and Document Control team s.
Support audit and inspection readiness activitie s.
Track remediation progress and drive assigned deliverables to completio n. Required Qualificati onsBachelor's degree in Engineering or related fie ld.3+ years of medical device industry experien ce.
Strong knowledge of Design Controls, DHF documentation, and Quality Syste ms.
Experience with risk management documentation (DFMEA, Hazard Analysis, Risk Control s).Familiarity with product lifecycle documentation and engineering change process es.
Strong technical writing, documentation, and problem-solving skil ls. Preferred Qualificat ionsExperience with DHF remediation proje cts.
Knowledge of FDA Quality System Regulations and medical device standa rds.
Experience supporting audits and regulatory inspecti ons.