Senior Manufacturing Engineer - Catheters

A contract manufacturing client looking for a direct hire Senior Manufacturing Engineer in Santa Clara, CA who can bring innovation and creative thinking to the team on catheter-based devices. As a Senior Manufacturing Engineer, you will be primarily responsible for maintaining, developing, and implementing cost-effective manufacturing processes and methods. You will provide day to day support of the catheter manufacturing floor operations from an engineering perspective. Senior Manufacturing Engineers document processes, implement ideas and solutions to improve assembly operations and reduce costs, develop tooling/fixturing, drive investigations tied to non-conformances. Experience with validations, risk management, and Lean Principles is preferred.

ESSENTIAL RESPONSIBILITIES

• Develops and implements robust cost-effective manufacturing processes, and improves product flow and product quality and safety performance for both sustained and new products
• Leads design transfer of new products to production including establishing assembly time and yield targets, training needs and quality control
• Develops, tests and implements tools, fixtures and equipment required for manufacturing processes
• Develops manufacturing process instructions, inspection plans and lot history travelers
• Leads creation of manufacturing process validation plans, validation protocols and reports, and implements manufacturing process validations and test method validations
• Collaborates with cross-functional teams during development phase(s), and provides inputs and recommendations for design for manufacturability (DFM)
• Develops and maintains process risk documentation (e.g. PFMEA) to identify potential risks, and implement preventive and corrective actions
• Manages and/or supports production and test equipment maintenance, qualification and calibration
• Performs analysis for cost reduction, and quality and efficiency improvement
• Prepares engineering change orders and coordinates the implementation of changes including training production staff
• Troubleshoots designs and processes when defects occur, leads investigation to determine root cause and implements effective containment and counter measures
• Dispositions non-conforming products and develops required re-work procedures
• Communicates with customers regarding process improvements and production changes

QUALIFICATIONS

• BS in Mechanical / Industrial Engineering or in an equivalent engineering discipline
• 5+ years of experience in catheter manufacturing/process development
• Experience in medical device manufacturing
• Experience with lean manufacturing techniques, value stream mapping, and continuous improvement methodologies preferred
• Solid knowledge of GMP and ISO 13485 regulations
• Must be proficient in Solidworks and must be able to interpret technical drawings and specifications
• Strong computer skills, including the MS Office suite
• Must be able to read, write and speak fluent English, and must possess excellent communication skills, both written and oral
• Must have demonstrated organizational skills to manage multiple priorities and schedules

Salary of $130-140K + bonus