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Responsibilities:

• Provide design solutions for a broad range of patient-specific implants inclusive of instruments and trials where necessary;
• 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;
• Provide adequate information via technical drawings and 3D models to manufacturing and inspection (including subcontractor activities such as coating requirements) and prepare job cards and bill of materials (BOMs) with reference drawings as required;
• Where required, dimension all drawings correctly, apply geometrical tolerancing, finishing and etching details, and carry out tolerance stack calculations;
• Perform engineering calculations, making reasonable assumptions, to support design validity;
• 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/OR staff, distributors, and the Sales team with respect to implant design, instrumentation and technical support;
• Ensure standard templates used for design are current and updated in a timely fashion;
• 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, as required;
• Any other tasks that sits outside your current role from time to time to support the activities of the business.

Requirements:

• 0+ years of experience
• 4-year degree in Engineering, BME or ME preferred