Senior Design Engineer

Executes engineering and design functions related to manufacturing, product development and improvement projects. Includes design and development, design review, continuous 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:

  • Lead Design Engineer for new product development projects and product improvement projects.
  • Manage instrument design projects to create customer instruments (specials) for surgeon specific user needs.
  • Interact directly with internal stakeholders, consulting surgeons, and manufacturing contractors to facilitate appropriate design.
  • 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 of budgets and timelines for product development projects.
  • Required Qualifications:

    • 4yr College Degree – BS in Engineering. Masters in Engineering preferred.
    • Minimum 5 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:

    License/Certification:

    Travel Required:

    yes