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Sr. Hardware Design Assurance Engineer

QualStaff Resources

Sr. Hardware Design Assurance Engineer

Irvine, CA
Full Time
Paid
  • Responsibilities

    Job Description

    SUMMARY/OBJECTIVE: The Senior Design Assurance Engineer is responsible for pre-market Design Quality Assurance related activities for the design and development of electronic hardware.

     

    ESSENTIAL DUTIES AND RESPONSIBILITIES

    [Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.]

    • Design Assurance Responsibilities

    o        Maintains compliance with design control activities per 21 CFR 820.30 and ISO 13485:2016.o        Authors or provides input to design verification activities, including master verification planning, protocol development, data collection and analysis, and reporting.o        Works with R&D for the creation of design input and output documents.o        Performs test method validations and capability analyses.o        Manages design review activities related to hardware.o        Ensures product requirements traceability from user needs to design verification test reporting.o        Works with outside agencies for product testing to ensure product meets electrical safety and reliability requirements.o        Works within the document control system to author, route, and approve controlled documents.o        Collaborates with the Commercial team and R&D regarding Human Factors testing.o        Works with R&D in the development and test of hardware testing tools.o        Collaborates with R&D on hardware design-related risk management activities. 

    • General Duties

    o        Participates in third party and internal quality audits involving areas of responsibility. o        Establishes, maintains Standard Operating Procedures and Forms related to areas of responsibility.o        Advises and trains other Company personnel concerning areas of responsibility.o        Communicates information related to quality management system effectiveness. o        Works in accordance with quality system procedures. Other duties as assigned by Supervisor.