Patient Specific Automation Engineer

Restor3d Inc

Durham, NC

JOB DETAILS
SKILLS
3D Modeling, Analysis Skills, Automation, Automation Engineering, Automation Systems, Best Practices, Biomedicine, Bug Tracking Software, CAD/CAM (Computer-Aided Design/Computer-Aided Manufacturing), Code of Federal Regulations, Continuous Improvement, Corrective Action, Creo Elements/Pro, Cross-Functional, Debugging Skills, Documentation, FDA (Food and Drug Administration), Git, Human Anatomy, ISO (International Organization for Standardization), Identify Issues, Implants, Maintain Compliance, Medical Equipment, Object Oriented Programming (OOP), Oncology, Problem Solving Skills, Process Engineering, Product Development, Production Support, Python Programming/Scripting Language, Regulations, Regulatory Compliance, Reporting Skills, Requirements Management, Rhino, Scalable System Development, Scripting (Scripting Languages), Software Administration, Software Design, Software Development, Software Validation, SolidWorks, Source Code/Configuration Management (SCM), Technical/Engineering Design, Test Automation, Testing, Time Management, Validation Testing
LOCATION
Durham, NC
POSTED
3 days ago

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)

About the Company

R

Restor3d Inc