Senior Design Engineer

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