Principal Design Engineer

Process owner of all engineering and design activities related to the design, development and improvement of Wenzel Spine products. Includes design control, design review, post-market improvement, and risk management functions. Provides direct support for QMS, Regulatory, and Operational activities as they relate to product development, improvement, and manufacturability. Reports directly to Director of Product Development.

Job Type:

Full Time

Location:

Austin

Job Functions:

  • Team Lead and Project Manager for new product development projects and product improvement projects.
  • Owner of design control processes for all maintenance/new development projects.
  • Interact directly with surgeon customers, manufacturing partners, and internal project stakeholders to solicit feedback on new product & instrument development projects.
  • Develop and maintain design history documentation for all product development projects.
  • Develop, implement, and maintain risk management files for all product development projects.
  • Generate 3D part files, 3D assembly files, and 2D technical drawings.
  • Work in conjunction with Quality and Regulatory departments to continually improve the Quality Management System as it relates to product development activities
  • Assist in creation and management of budget, timelines, and resourcing for all product development projects.
  • Assist in development and management of patent portfolio and product development pipeline.
  • Report project status to executive staff on a routine basis.
  • Act as a trusted resource for product and procedural subject matter expertise.
  • Required Qualifications:

    • BS in Engineering, or equivalent industry experience. Masters in Engineering preferred.
    • Minimum 8 years design/development experience in the medical device industry. Orthopedic spine experience strongly preferred.
    • Experience working in a ISO 13485 and FDA compliant quality system environment
    • Strong computer skills, to include: Outlook, Excel, Power Point, and Word.
    • Extensive experience using 3D CAD software, preferably SolidWorks.
    • Experience specifying and interpreting Geometric Dimensioning and Tolerancing (GD&T) per ASME Y14.5
    • Strong work ethic, highly motivated self-starter, with excellent presentation skills.

    Experience:

    Education:

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    Travel Required:

    yes