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    Senior Development Engineer - San Diego, United States - Resonetics

    Resonetics
    Resonetics San Diego, United States

    1 week ago

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    Description

    Overview:

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

    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
    Compensation:

    Salary- $95,000-120,000

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