Work Flexibility: Hybrid

Responsibilities

• 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.
• Any other tasks that sits outside your current role from time to time to support the activities of the business.

Skills & Experience -

• Minimum of Bachelor’s degree in a science, engineering or related discipline. Mechanical or Biomedical Engineering preferred. Advanced degree in a technical discipline preferred.
• 2-3 years’ experience in medical device industry preferred, Overall, 5-8 years’ experience 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 interprete Voice of customer and draft design controls in compliance to ISO 13485, ISO 14971.
• Draft, tolerance and apply GD&T correctly and precisely
• Can support various departments, including manufacturing and inspection, regulatory and other functions and maintain strict document control.
• Can manage and schedule multiple projects both short and long term and keep to strict deadlines in a methodical manor.
• Self-motivation and focus to work individually or in small team environments.
• An eye for creative/innovative design and attention to detail.
• Understanding of biomedical and biomechanical engineering, bio tribology, or biomaterials.

Travel Percentage: 10%