Job details
What you will do-
- Translate design inputs to engineering specifications and produce sub-system level designs; apply fundamental and some advanced concepts, practices and procedures for problem solving
- Technical ability to create engineering drawings and models, applying tolerances and GD&T precisely.
- Demonstrated ability to apply knowledge of materials and manufacturing processes to product design; use of CAD to a high level to design 3D parametric/non-parametric models and assemblies taking into consideration manufacturing and inspection routes. and manage and schedule multiple projects both short and long term and keep to strict deadlines in a methodical manner.
- Under minimal supervision and tight timelines, research, design, and develop design solutions for a broad range of patient specific implants (knees, hips) inclusive of instruments and trials where necessary; manage case project throughout from case assignment through design, development, manufacturing, to shipment.
- Read and work from various clinical imaging including x-rays, CT, and MRI scans and interpret Voice of customer and draft design controls in compliance to ISO 13485, ISO 14971; prepare 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; with customers (surgeons, surgical/theatre staff) as well as internal stakeholders (sales team) with respect to implant design, instrumentation and technical support.
- Ensure all solutions meet critical design prerequisites including patient and customer safety, mechanical, and biological suitability; demonstrate proficiency with product’s intended use and clinical procedures
- 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;
- Support various departments, including manufacturing and inspection, regulatory and other functions and maintain strict document control
- Attend surgical and clinical cases, both domestic and abroad as required.
What you will need-
Required skills-
- Minimum of Bachelor’s degree in a science, engineering or related discipline with 2-6 years of industry experience. Mechanical Engineering preferred. Advanced degree in a technical discipline preferred.
- Experience - 2 years- 6 years; medical device industry experience
Preferred Qualifications-
- Good understanding of Creo, Materialise 3Matic, understanding CT scan, segmentations of bone models, anatomy of Hip & knee joints
- Previous customer facing role in technical capacity.
- Understanding of biomedical and biomechanical engineering, bio tribology, or biomaterials.
