Patient Specific Design Engineer

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

Essential Duties and Responsibilities:

Design Patient Specific Orthopedic Implants

Analyze and understand CT scan data and how it translates to 3D modelsProduce surgical simulations (resections, alignments, etc.)Design patient specific implants based on surgeon input and measurements with quick turnaround timesDesign implant trials, cutting guides, or other instrumentation needed for implant placementContribute to efforts to improve team efficiency and case throughput

Draft Project Documentation

Produce case specific surgical technique guidesDetermine inspection criteria and perform mechanical strength analyses for designated casesProduce accurate quality documentation relevant for designated case typesContribute to efforts to improve quality in all processes and reduce non conformances

Design for Manufacturing

Work closely with operations to ensure manufacturability of design workModify designs for printability based on the type of printer to be used (FDM, SLA, DLP, SLS)Contribute to efforts to improve first pass manufacturing yield of complex designs

Clinical Representative

Lead virtual design calls with surgeons to gather design inputs.Attend orthopedic cases and verbally assist in surgical process and patient specific device related surgical steps

Other responsibilities as assigned.

Qualifications:

Bachelor of Science in an engineering or equivalent discipline (Biomedical or Mechanical Engineering preferred)Experience in 3D modeling (Solidworks, ProE, 3-matic, Fusion360, Rhino, Blender, etc.)Willingness to work a flexible schedule to accommodate design call and case volumesUnderstanding of human anatomy (through coursework or training)Independent worker looking to learn and develop new designs and efficiency improvementsExperience 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 fieldsOrthopedic implant design and development experienceExperience with custom order engineeringExperience 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.