Design Engineer

restor3d, Inc.; United States; On-site; USD 90,000 - 130,000; Full time

Job summary

restor3d, Inc. seeks a Patient Specific Design Engineer to collaborate with surgeons to create customized implants and instruments for orthopedic cases. You will translate CT data into 3D models and design implants with input from surgeons, ensuring manufacturability for production by the operations team.

You will lead design activities, set acceptance criteria, and document designs and testing. A strong background in 3D printing and medical implant design under quality management is required.

Qualifications

• BS in engineering or equivalent; Biomedical or Mechanical preferred.
• Extensive 3D modeling experience with common CAD tools.
• Experience with design and manufacturing of medical implants and quality systems (ISO 13485, FDA 21 CFR 820).
• Experience with 3D printing and rapid prototyping.

Responsibilities

• Collaborate with surgeons to design patient-specific orthopedic implants and instruments.
• Translate CT data into accurate 3D models and designs.
• Ensure manufacturability and design-for-manufacturing considerations.
• Lead design reviews and set acceptance criteria for various case types.
• Produce design documentation and ensure timely delivery per processes.
• Improve manufacturing yield and design efficiency for complex cases.

Skills

3D modeling

SolidWorks

Pro/E

Fusion 360

Rhino

Blender

Anatomy knowledge

Communication

Attention to detail

Self-motivation

Education

Bachelor of Science in engineering

Biomedical or Mechanical Engineering

Tools

3D printing

Fusion 360

Rhino

SolidWorks

Job description

The Patient Specific Design Engineer will be responsible for collaborating closely with surgeons to create customized implants and instruments for a range of orthopedic uses.

Duties and responsibilities

• Develop and maintain strong internal working relationships across restor3d.
• Understand the objectives, responsibilities, and mission of the Digital Production department and work towards those goals.
• Prioritize and plan work activities; adapt for changing conditions.
• Design Patient Specific Orthopedic Implants
• Analyze CT scan data and translate into 3D models
• Design implants based on surgeon input and measurements with quick turnaround times
• Design implant trials, cutting guides, or other instrumentation needed for implant placement
• Lead call prep and design activities on complex and new case types
• Set design acceptance criteria for each case type within focus area
• Draft Project Documentation
• Determine inspection criteria and perform mechanical strength analyses for designated cases
• Produce accurate quality documentation relevant for designated case types
• Design for Manufacturing
• Work closely with operations to ensure manufacturability of design work
• Modify designs for printability based on the type of printer to be used (FDM, SLA, DLP, SLS)
• Lead efforts to improve first pass manufacturing yield of complex designs
• Clinical Representative
• Attend orthopedic cases and verbally assist in surgical process and patient specific device related surgical steps
• Managerial Responsibilities
• Liaison with commercial team to gather relevant case information and assign cases to engineers
• Assist in scheduling cases with input from the commercial and operations teams
• Delivery of designs and documentation on-time per approved processes
• Reduce digital production COGS of designated cases by driving efficiency improvements
• Reinforce a quality-centric attitude to the team
• Other responsibilities as assigned.

Qualifications and experience

• Bachelor of Science in engineering or equivalent discipline (Biomedical or Mechanical Engineering preferred)
• Extensive experience in 3D modeling (Solidworks, ProE, 3-matic, Fusion360, Rhino, Blender, etc.)
• Independent workers looking to learn and develop new designs and efficiency improvements
• Self-starter willing to take ownership of designated case types
• Willingness to work a flexible schedule to accommodate design call and case volumes
• Understanding of human anatomy (through coursework or training)
• Experience with design and manufacturing of medical implants (ISO 13485 and FDA 21 CFR 820)
• Experience working under a quality management system for medical devices or other regulated design fields
• Orthopedic implant design and development experience
• Experience with custom order engineering
• Experience with 3D printing

Required Skills:

• Excellent written and verbal communication skills.
• Able to work accurately in a fast-paced, hectic, ever-changing environment with strong attention to detail.
• Demonstrated ability to monitor own work to ensure quality, accuracy, and thoroughness.
• Strong organizational, analytical, and time-management skills.
• Able to self-motivate and work both independently and as part of a team.

Physical Requirements:

• Extended periods of sitting at a computer.