Senior Design Engineer

Job description

Work Flexibility: Hybrid 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 (Mechanical Engineering preferred); preferably in medical device industry. Experience - 4 years -6 years 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. Travel Percentage: None