Patient Specific Automation Engineer

restor3d
  • Durham, NC
    30+ days ago

    Job Description

    The Patient Specific Design Automation Engineer is responsible for developing and maintaining automation solutions that support the design of patient-specific orthopedic implants across multiple anatomical applications, including ankle, shoulder, hip, knee, CMF, trauma, and oncology. This role focuses on CAD and design automation to improve efficiency, scalability, and consistency in patient-specific engineering workflows. The engineer will collaborate cross-functionally with patient specific design engineers, process engineering, product development, and quality/regulatory teams to create robust automation tools that enhance design processes and support production needs.

     

    Duties and responsibilities

    • Develop, implement, and maintain automation scripts and tools to support patient-specific implant design workflows.
    • Improve and optimize CAD workflows for automation focusing on efficiency and repeatability across multiple product lines.
    • Create automation solutions for generation of reports and documentation associated with patient specific engineering outputs.
    • Build on existing scalable code infrastructure supporting automation platforms and design systems.
    • Gather and analyze requirements from internal stakeholders to define automation opportunities and technical specifications.
    • Test, validate, and troubleshoot automation scripts to ensure reliability and compliance with design requirements.
    • Investigate software bugs, track issues, and implement corrective actions in a timely manner.
    • Collaborate closely with patient specific design engineers to understand workflow pain points and translate needs into technical solutions.
    • Support continuous improvement initiatives related to automation, digital workflows, and engineering productivity.
    • Maintain documentation for software tools, code changes, validation activities, and process updates in accordance to FDA regulated device software as applicable

     

    Qualifications include:

    • Proficiency in python programming, including object-oriented programming principles, modular code development, debugging, and version control using Git within shared code bases.
    • Bachelor of Science in an engineering discipline (CS, mechanical, biomedical, etc.)
    • Strong analytical, problem solving, and troubleshooting skills
    • Ability to work effectively in cross-functional team environments
    • Independent worker willing to learn and develop necessary design, and software skills though guided trainings and self-guided research
    • Self-starter willing to take ownership of assigned projects

     

    Preferred qualifications include:

    • Experience in 3D modeling and CAD design (3-matic, Solidworks, ProE, Fusion360, Rhino, etc.)
    • Knowledge of automation testing and software verification and validation best practices
    • Understanding of human anatomy (through coursework or training)
    • Experience with medical device design (ISO 13485 and FDA 21 CFR 820)

    Numbers & Facts

    LocationDurham, NC

    Skills

    • 3D Modelingunmatched
    • Analysis Skillsunmatched
    • Automationunmatched
    • Automation Engineeringunmatched
    • Automation Systemsunmatched
    • Best Practicesunmatched
    • Biomedicineunmatched
    • Bug Tracking Softwareunmatched
    • CAD/CAM (Computer-Aided Design/Computer-Aided Manufacturing)unmatched
    • Code of Federal Regulationsunmatched
    • Continuous Improvementunmatched
    • Corrective Actionunmatched
    • Creo Elements/Prounmatched
    • Cross-Functionalunmatched
    • Debugging Skillsunmatched
    • Documentationunmatched
    • FDA (Food and Drug Administration)unmatched
    • Gitunmatched
    • Human Anatomyunmatched
    • ISO (International Organization for Standardization)unmatched
    • Identify Issuesunmatched
    • Implantsunmatched
    • Maintain Complianceunmatched
    • Medical Equipmentunmatched
    • Object Oriented Programming (OOP)unmatched
    • Oncologyunmatched
    • Problem Solving Skillsunmatched
    • Process Engineeringunmatched
    • Product Developmentunmatched
    • Production Supportunmatched
    • Python Programming/Scripting Languageunmatched
    • Regulationsunmatched
    • Regulatory Complianceunmatched
    • Reporting Skillsunmatched
    • Requirements Managementunmatched
    • Rhinounmatched
    • Scalable System Developmentunmatched
    • Scripting (Scripting Languages)unmatched
    • Software Administrationunmatched
    • Software Designunmatched
    • Software Developmentunmatched
    • Software Validationunmatched
    • SolidWorksunmatched
    • Source Code/Configuration Management (SCM)unmatched
    • Technical/Engineering Designunmatched
    • Test Automationunmatched
    • Testingunmatched
    • Time Managementunmatched
    • Validation Testingunmatched

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