Medical Device Manufacturing Manager

Description

Manager, Medical Device Manufacturing

Primary responsibility for this position will be to provide leadership and execution of tasks within supply chain including a tier 1 electronics supplier and tier 2 custom component suppliers. 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

Responsibilities:

• Implement scale-up strategies within the supply chain comprising of tier 1 and 2 suppliers in support of commercial forecasts
• 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
• Establish a process capability monitoring program including project management of development programs for testers and data management systems.
• Lead manufacturing development on all matters including documentation, testing, component evaluation, process validations, failure analysis, performance monitoring, issue resolution; and processing engineering change orders.
• Manage and grow key supplier relationships as they pertain to successful manufacturing operations
• 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:

• Experience with medical product scale-up including automation development and NPI
• Electronics manufacturing experience including working knowledge of Surface Mount Technology (SMT)
• Experience with qualification of customer components including injection molded and stamped metal subassemblies.
• Knowledge of electromechanical assemblies and process techniques, automated test equipment, electrical testing, and ICT
• 10-12 years of experience working on electronic device manufacturing for medical product companies or other highly regulated industries.
• The ideal candidate will have a minimum of a B.S. in Mechanical, Electrical or Manufacturing Engineering.

To find out more about Real please visit www.realstaffing.com