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The R&D Engineer is responsible for the development of new medical device systems and/or the enhancement of existing products. The R&D Engineer will be involved in creating designs, 3D models, and drawings utilizing SolidWorks. Other responsibilities include assisting in the development processes for Manufacturing, Quality Control, Regulatory and Planning for their project.
• Research and develop spinal implants and instruments in accordance with FDA and ISO requirements.
• Create 3D part files and 2D technical drawings using SolidWorks and Adobe Acrobat.
• Analyze test data and generate reports to verify or validate that designs meet functional and performance specifications.
• Interact and coordinate with other departments to establish project plans, product requirements, and other documentation activities in accordance with design control and risk management procedures.
• Provide assistance to the Sales, Marketing, and Customer Service departments as needed.
• Interface with suppliers and provide support during the manufacturing process.
• Follow organizational and group guidelines, procedures, protocols.
• CAD experience required (SolidWorks preferred).
• Familiarity with product development cycle and phased approach.
• Knowledge of general manufacturing processes, and familiar with common materials and practices to produce medical devices.
• Experience with geometric dimensioning and tolerancing.
• Exposure and knowledge of ASTM, ISO, FDA standards, regulations, and guidelines.
• Be comfortable with autonomy of responsibility in addition to a team environment.
• Be adept and flexible to manage multiple tasks at once while keeping to the set schedule of each task.
• Capable of presenting and sharing information with management, surgeons, and/or field personnel when requested (PowerPoint skills preferred).
EDUCATION and EXPERIENCE
BS in Mechanical Engineering or Biomedical Engineering, and 1-3 years of experience required.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee is occasionally required to stand; walk; use hands to finger, handle, or feel; and reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Working environment is typical of an office environment. The noise level in the work environment is usually moderate.