Senior Design Engineer

Overview

Senior Design Engineer role focused on designing patient-specific implants (knees, hips), including instruments and trials, from case assignment through manufacturing and shipment.

What you'll do

• Translate design inputs into engineering specifications and produce sub-system level designs, applying fundamental and some advanced concepts, practices and procedures for problem solving.
• Create engineering drawings and models, applying tolerances and GD&T precisely.
• Apply knowledge of materials and manufacturing processes to product design.
• Use CAD at a high level to design 3D parametric/non-parametric models and assemblies, taking manufacturing and inspection routes into consideration.
• Manage and schedule multiple short and long term projects 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), including instruments and trials where necessary.
• Manage case projects throughout from case assignment through design, development, manufacturing, to shipment.
• Read and work from clinical imaging including x-rays, CT, and MRI scans.
• Interpret Voice of Customer and draft design controls in compliance with ISO 13485 and ISO 14971.
• Prepare surgical planning guides/instructions, including appropriate surgical instruments, and define 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 on manufacture and progress of each case.
• Liaise with customers (surgeons, surgical/theatre staff) and internal stakeholders (sales team) on 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 the product's intended use and clinical procedures.
• As part of a team, conduct risk assessments and document all activities and justifications/validations to satisfy regulatory requirements under guidance of 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'll need

• Minimum of a Bachelor's degree in a science or engineering field.
• Experience: 4 to 6 years.

Nice to have

• Mechanical Engineering degree (preferred).
• Experience in the medical device industry (preferred).
• Good understanding of Creo and Materialise 3Matic.
• Understanding of CT scans, segmentation of bone models, and anatomy of hip and knee joints.
• Previous customer-facing role in a technical capacity.
• Understanding of biomedical and biomechanical engineering, bio tribology, or biomaterials.

Details

• Work mode: Hybrid.
• Location: Gurugram, India.
• Travel: None stated.