Description
Position: Senior Manufacturing Test Engineer, Medical ProductsJob Description: This position will provide manufacturing and test engineering in support of development and commercial manufacturing of IT-101 and future products. Primary responsibility for this position will be to provide process engineering support for Incline'sEMS' operation. Given the company's culture of cross functional problem solving, the candidate will work closely with R&D, Quality Engineering, Production and Planning. Successful experience with new product development, NPI and ramp-up is critical. This position will be based inRedwood City at CA. Frequent travel to CMO inHuntsvilleAL and suppliers will be required.
This position will:
? Support manufacturing in all engineering issues including documentation, testing, component evaluation, process validations, failure analysis, performance monitoring, issue resolution; and processing engineering change orders.
? Establish a process capability monitoring program including project management of development programs for testers and data management systems.
? Assist in achieving cost-of-goods reduction objectives.
? Coordinate product support with Production, R&D engineering, Quality, Planning and Purchasing.
? Implement process improvements, qualifications and validations, technical support, root cause analysis, and monitoring production metrics
? Work with R&D engineers and suppliers to concurrently evaluate products for manufacturability, and provide DfX analysis for both commercial and new product introductions.
Requirements:
The ideal candidate will have a minimum of a B.S. in Mechanical, Electrical or Manufacturing Engineering, and 5-8 years of experience working on electronic device manufacturing for medical product companies, or other highly regulated industries.
Required experience and skills:
? Electronics manufacturing experience including working knowledge of Surface Mount Technology (SMT).
? Experience with electromechanical assemblies and process techniques, automated test equipment, electrical testing, and ICT.
? Experience with medical product scale-up including automation development and NPI
? Strong knowledge of FDA Quality System Regulations
Additional desired experience and skills include:
? Experience with Statistical Process Control, Design of Experiments, Just in Time, and Lean manufacturing techniques.
? Involvement with failure analysis programs.
? Knowledge of ISO Quality System Regulations
To find out more about Real please visit www.realstaffing.com