What you will do:
• Ensure all solutions meet critical design prerequisites including patient and customer safety, mechanical, and biological suitability;• Read and work from various clinical imaging including x-rays, CT, and MRI scans• Preparation of surgical planning guides/instructions inclusive of appropriate surgical instruments and defining operating instructions for patient-specific implants;• Liaise with Design coordinators, Manufacturing Team Leaders and technicians, Product Engineers, Inspectors, Customer Services, QA/RA personnel, and subcontractors with respect to the manufacture and progress of each case; • Liaise with consultant surgeons, surgical/theatre staff, distributors, and the Sales team with respect to implant design, instrumentation and technical support;• Ensure all patient-specific designs are covered by an appropriate Technical File/Design Dossier/Device History File;• Conduct, as part of a team, risk assessments and document all activities and justifications/validations to satisfy regulatory requirements under the guidance of the Quality and Regulatory Affairs counterparts;• Attend surgical and clinical cases, both domestic and abroad as required.
What you need:
• 5-8 years’ experience preferred (2-3 years’ experience in medical device industry preferred• Good understanding of Creo, Materialise Mimics - segmentations of bone models, understanding CT scan , Anatomy of Hip & knee joints will be preferred.• Can use CAD to a high level to design 3D parametric models and assemblies using Creo taking into consideration manufacturing and inspection routes.• Able to interpret Voice of customer and draft design controls in compliance to ISO 13485, ISO 14971.• Draft, tolerance and apply GD&T correctly and precisely
Bachelors
B.E
CAD,Creo,GD&T,Materialise Mimics,Design Controls,Risk Assessments ISO 13485,ISO 14971.,
Medical/Healthcare/Hospital