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Orthopedic Medical Device Design Engineer

Company: HCL America Inc.
Location: Austin
Posted on: March 28, 2020

Job Description:

4-6 years of mechanical medical device development experience, including implant and instrumentation in the field of orthopedics. Specialize in Orthopedic reconstruction and trauma, spine, sports medicine, Orthopedic extremities or foot and ankle. Basic Techniques in ORIF Bone Handling Techniques. Joint AspirationUltrasound Techniques. Upper Extremity Arthroscopy. Lower Extremity Arthroscopy. Basic Ortho Surgical Techniques. Knowledge of FDA GMPs, ISO 134852016, ISO 149712012. Knowledge in the application of design controls. Knowledge of process validation IQOQPQ. Development and execution of design verificationvalidation plans, test methods and protocols, and will support regulatory processes for global registration efforts. Experience in designing complex medical device products on time (concept to launch). Significant understanding and working knowledge of manufacturing processes, materials and quality assurance protocols. Sound understanding of human bone joints such as knee, hip and extremities and joint kinematics. Understanding of different types of manufacturing, mechanisms, materials, proper tolerance, drafting standards, and GDT. Experience with CAD software (Pro-E, Creo, Solidworks, etc.)bull Proficiency utilizing the MS Office Suite (Word, Excel, PowerPoint, etc). Experience using statistical tools to improve quality. Experience working with surgeons and other healthcare professionals

Keywords: HCL America Inc., Austin , Orthopedic Medical Device Design Engineer, IT / Software / Systems , Austin, Texas

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