Sr. Development Engineer

Karwell Technologies

  • Warsaw, IN
  • 7 days ago

    Highlights

    Summary: Responsible for the post market activities of existing Design History Files for Medical Devices under the direction of a project leader or manager. Ability to effectively work within a team to expedite completion of critical project tasks with cross functional groups including Regulatory and Quality.

    Numbers & Facts

    LocationWarsaw, IN

    Description

    Summary:
    • Responsible for the post market activities of existing Design History Files for Medical Devices under the direction of a project leader or manager.
    • Previous system experience with Vault is preferred.
    • Excellent communication, teamwork, and organizational skills are essential.
    • Candidates must be self-starters and self-motivators. .
    Roles and Responsibilities:
    • Author and Review existing Design History Files, identify scope, and mark gaps where necessary documents are missing
    • Utilize Vault Systems to manage Document workflow
    • Generate or analyze and update existing risk documentation (DFMEA or risk tables)
    • Coordinate, prepare, and conduct design reviews with cross-functional teams
    • Perform functional relationship analyses (FRA) and tolerance stack-ups
    • Generate comprehensive protocols to test/analyze the product for design verification and design validation (V&V)
    • Update prints and other design and manufacturing elements
    Requirements:
    • Familiarity with Vault Systems
    • Familiarity with drafting standards and geometric dimensioning and tolerancing (GD&T)
    • Strong Background in DHF documentation authoring and executing for Medical Devices
    • Ability to effectively work within a team to expedite completion of critical project tasks with cross functional groups including Regulatory and Quality
    • Establishing a process method which meets performance and quality requirements
    • Ability to give clear and concise oral presentations
    • Technical writing
    • Microsoft Office Suite
    • B.S. degree from an ABET accredited school (or global equivalent) in Biomedical, Mechanical, or Materials engineering, or equivalent.

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