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Careers
Title: Project Engineer
Reports to: Director of Marketing, Spine/Recon
Direct Reports: None
Key Objective:
To support product development by coordinating the efforts of Research, Testing, Production/Manufacturing, and Quality to develop resorbable medical implants for spine, orthopedic and soft tissue applications.
Responsibilities:
- Generating prototype models to evaluate new design concepts
- Designing for manufacture and inspection
- Completing necessary analysis of new designs
- Coordinating the development of comprehensive protocols and reports for testing the product
- Coordinating product evaluation and design validation
- Generating design assurance documentation for the project (Design History Files). This documentation includes the development of design inputs, design outputs, risk analysis (Hazard Analysis & FMEA), functional performance requirements (design verification), and design validation
- Conducting regular project meetings and periodic design review meetings
- Initiating Change Orders and/or coordinating the completion of Change Orders
- Maintain contact with the market during projects through contact with the distribution partner, and/or through various trade shows, courses, etc.
Position Requirements:
- Bachelor's degree in Mechanical or Biomedical Engineering
- At least 3 years experience in the Medical Device Industry
- Experience with solid-modeling software (Pro/Engineer, Pro/Intralink)
- Knowledge of ASME Y14.5M-1994 GD&T Standards
- Knowledge of FDA-QSR and ISO requirements
- Knowledge of resorbable polymers
- Experience with polymer processing
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