Description
GENERAL DESCRIPTION:Responsible for influencing design durability and usability of new products and line extensions within the new product development environment.
ESSENTIAL FUNCTIONS:
- Monitor and influence progress of R&D projects to ensure sound application of engineering principles, satisfaction of user needs, and clinical relevancy is being achieved.
- Evaluates/improves the robustness of new products/line extensions through design and/or testing
- Predicts potential failure modes of new product design and offers input/improvements to cross functional design team
- Designs and/or implements methods and procedures for inspecting, testing, and evaluating the consistency and durability of products and/or production and/or test equipment.
- Perform validation for medical devices, ensuring that proposed designs meet or exceed defined user needs
- Perform and/or supervise validation of production processes and/or test procedures/fixtures
- Select, analyze, design, and improve mechanical and/or electrical manufacturing and/or inspection procedures for medical devices.
- Analyzes reports and/or returned products and recommends corrective action.
- May interact with customers to solve reliability issues and/or answer general product questions.
- May train others in quality assurance/GMP related topics.
- Develop and execute process and product protocol.
- Knowledge of applicable domestic and international regulations and standards (QSR, MDD, ISO 13485 and CMDCAS).
- Develop statistical process controls and analyze data. Optimize operating parameters.
- Analyze and improve computer test software, verification and validation equipment, inspection equipment, and process/manufacturing equipment
To find out more about Real please visit www.realstaffing.com