• Design Assurance Engineer

    May 15, 2017 • Careers

    Position Description
    This position is responsible for Design Quality Assurance and will ensure quality system compliance related to product design. This role will be a key member of cross functional product development teams and must be a confident contributor with the intellectual curiosity to take on new challenges. The qualified candidate must be comfortable in a fast-paced environment and capable of navigating multiple projects with competing priorities. Team will depend upon this individual to offer guidance on design assurance requirements specifically and quality management system topics generally.

    Areas of Primary Responsibility
    – Ensure that product development plans are established and executed in compliance with corporate procedures and relevant international standards,
    – Establish Risk Management Plan(s) for product development efforts and ensure that they are executed in compliance with relevant international standards
    -Lead Risk Analysis activities and ensure compliant execution
    – Perform independent technical assessment of product quality and supporting activities/documentation, including the development of User Needs and Product Specifications and the successful completion of Design Verification and Design Validation
    – Ensure that the Design History File is compiled and includes all relevant product development documentation
    – Support quality-related problem solving and root cause analysis during design and manufacturing

    – 5+ years of design assurance experience in the medical device industry
    – Able to lead preparation and execution of Risk Management documentation (e.g., Risk Management Plans, Hazard Assessments, FMEAs)
    – Knowledge of and experience working with FDA Quality Systems Regulations and the following standards:
    o ISO 13485
    o ISO 14971
    o IEC 60601 (a plus)
    o IEC 62304 (a plus)
    – Participation on cross-functional project teams (e.g., including Product Development, Marketing, Manufacturing)

    Skills and Traits
    – Critical thinking
    – Presentation of data
    – Teamwork, flexibility and adaptability
    – Written and oral communication
    – Self-initiator
    – Highly organized
    – Ability to negotiate and lead through influence

    How to Apply:
    Submit your resume and cover letter to careers@csamedical.com
    CSA Medical, Inc. is an equal opportunity employer.
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