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    Development Engineer - San Diego, CA, United States - Resonetics

    Resonetics
    Resonetics San Diego, CA, United States

    3 weeks ago

    Default job background
    Description

    Overview:

    Part of a cross-functional engineering team driving the design, development, verification, and manufacturing transfer of novel interventional medical devices.


    Salary $95,000-$120,000


    Responsibilities:
    Lead project teams through novel interventional device development while providing technical oversight, budget and timeline management, and effective customer communication
    Set direction on core technical strategies for development programs
    Mentor junior resources
    Summarize and refine product specifications
    Brainstorm novel therapeutic concepts
    Perform concept refinement and generate detailed CAD design
    Prototype and evaluate catheter-based designs
    Perform engineering calculations, including tolerance analysis
    Develop and maintain drawing packages
    Develop in-vitro test methods, including fixture design and fabrication
    Perform in-vivo and in-vitro study protocol development, execution, reporting
    Develop manufacturing processes and documentation
    Create and maintain design controls documentation
    Generate product risk analyses
    Foster client relationships and provide responsive service in a contract environment
    Adhere to Quality Management System procedures/design controls
    Participate in internal technical or process improvement initiatives
    Prepare proposals, including definition of scope, timeline, and budget
    Other duties as assigned


    Qualifications:
    A minimum of 5 years experience in medical device development
    Proficiency in MS Office suite and SolidWorks
    Attention to detail and comfort working in a regulated industry
    Ability to present and convey complex engineering ideas to internal stakeholders and external customers
    Ability to create job-related documentation for quality purposes
    Ability to quickly and positively adapt to changing priorities and processes (product of input on multiple projects in customer-driven environment)
    Strong communication and organizational skills
    Ability to work under minimal supervision
    Familiarity with ISO 13485 and 21 CFR
    #J-18808-Ljbffr
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