Your responsibilities

• Designs and develops new implants and instrumentation and develops improvements and modifications to current products
• Interacts with surgeons, manufacturing, regulatory affairs, sales consultants, product managers, and other functional departments to define and develop product requirements and concepts
• Supports project lead and other core team members in commercialization of product.
• Works directly with surgeons for design concept development, prototype and cadaver evaluation, and clinical follow-up
• Generates product models, concept layouts, and prints using a CAD software. Apply geometric dimensioning and tolerancing accordingly
• Performs the required activities and generates the appropriate documents to ensure compliance with FDA Design Control regulations, and to support 510(k) submissions or IDE clinical studies
• Develops mechanical test protocols according to ASTM standards and coordinates the activities required to fabricate test parts and complete mechanical testing
• Works with manufacturing during the design stages to incorporate manufacturability into the product designs
• Responsible for all the designs from concept development through product launch.
• Responsible for initial patent review of designs for freedom to operate
• Know and follow all laws and policies that apply to one's job, and maintain the highest levels of professionalism, ethics and compliance at all times
• Performs other special projects and functions as assigned by the department manager
• Knows basic company practices, procedures, policies and job tasks. Applies knowledge of standard concepts and principles that apply to job assignments.
• Works on a variety of problems of moderate scope and complexity. Tasks are well defined, has some latitude to determine procedures.
• Objectives and methods are predetermined. Work is closely supervised.

Your qualifications

• 3-5 years of experience in the design and development of mechanical products
• Knowledge of CAD software (SolidWorks, Pro-E, etc.) preferred
• BS Biomedical Engineering, BS Mechanical Engineering, BS MET (or equivalent) required
• Experience in medical device industry desirable
• Strong communication and interaction skills, with the ability to interface with surgeons and sales/marketing personnel
• Demonstrated creative design ability
• Demonstrated success in developing finished design specifications

What we offer