Senior Patient Specific Design Engineer

Job Summary :

Any additional information you require for this job can be found in the below text Make sure to read thoroughly, then apply.

The Sr. Patient Specific Design Engineer is responsible for leading a team of engineers to design patient-specific orthopedic implants by analyzing CT scan data, producing 3D models and surgical simulations, ensuring manufacturability, drafting detailed documentation, and maintaining high quality and efficiency standards.

Essential Duties and Responsibilities :

• Develop and maintain strong internal working relationships across restor3d.
• Understand the objectives, responsibilities, and mission of the Patient Specific 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.
• Produce surgical simulations (resections, alignments, etc.).
• 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
• Produce case specific surgical technique guides.
• 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
• Lead team of engineers responsible for design of designated case types.
• Liaison with commercial team to gather relevant case information and assign cases to engineers.
• Assist in scheduling of cases with inputs from the commercial and operations teams.
• Responsible for training of team members to designated case types.
• 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 :

• Bachelor of Science in an engineering or equivalent discipline (Biomedical or Mechanical Engineering preferred).
• Extensive experience in 3D modeling (Solidworks, ProE, 3-matic, Fusion360, Rhino, Blender, etc.).
• Leadership experience.
• 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.

Skills, Abilities, Competencies Required :

• 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.
• Independent worker 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.

restor3d is an Equal Opportunity Employer.

J-18808-Ljbffr