Sr Manufacturing Mechanical Engineer - Shockwave

Sr. Manufacturing Engineer, Shockwave Medical

Location:

Santa Clara, CA

The Senior Manufacturing Mechanical Engineer will be responsible for technical support to the contract manufacturers and component suppliers on the implementation and validation of manufacturing lines for Shockwave products. Including evaluation and building of prototypes, pilot, and production equipment or tooling as appropriate, troubleshooting and implementing changes to improve manufacturing quality and product performance. The Senior Engineer will assist in the identification and pursuit of value improvement and cost improvement projects to support operations in line with business goals and objectives.

• Acts as the primary technical point of contact; works with our contract manufacturer and external partner to transfer and scale Shockwave manufacturing process.
• Supports development transfer activities from R&D & Operations to contract manufacturer/suppliers.
• Works with local, international suppliers and manufacturing sites to generate capacity/capability models and make vs. buy assessments used as an input to site planning.
• Responsible for preparation and execution of validation protocols and completion of validation reports.
• Develops and maintains process risk documentation (e.g., PFMEA) to identify potential risks and implement preventive and corrective actions.
• Prepares engineering change orders and coordinates the implementation of changes including training production staff.
• Provides expertise in project planning and timeline development & management and maintain project schedules and timelines.
• Implements and manage process improvement and cost reduction projects.
• Ensures capacity is appropriate for the manufacturing plan.
• Effectively utilizes lean manufacturing tools for continuously improving the flow of material and information in the factory including factory layouts, visual management, 6S, JIT, Kanban.
• Implement robust cost-effective manufacturing processes and improve product flow and product quality and safety performance for both sustained and new products.
• Collaborates with cross-functional teams during development phase(s) and provides inputs and recommendations for design for manufacturability (DFM).
• Develops, tests, and implements tools, fixtures and equipment required for manufacturing processes.
• Support improvements for mechanical equipment features like 3D Printing, UL Impact testing, and Material selection.
• Develops manufacturing process instructions, inspection plans and lot history travelers.
• Performs analysis for cost reduction, and quality and efficiency improvement.
• Leads design transfer of new products to production including establishing assembly time and yield targets, training needs and quality control.
• Assists suppliers in product failure investigations required to determine root cause, improve product reliability, performance improvement as well as effective containment and counter measures.
• Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements (ISO), Company policies, operating procedures, processes, and task assignments.
• Performs other responsibilities and duties as assigned.

• Bachelor’s degree in Mechanical Engineering or related field.
• 5 years of experience in all phases of Process/Manufacturing development to launch for high volume commercial or medical devices and transfer of product lines externally.
• Strong problem solving and analytical skills; experience with use of statistical analysis and design of experiments for product optimization and validation activities.
• Excellent organizational, verbal, and written communication skills as well as attention to detail.
• Experience with lean manufacturing, design for manufacturability and test implementation.
• Experience with balloon/stent catheter manufacturing.
• Experience with braiding, coiling & laser processing operations a plus.
• Proficient with Solid Works a plus.
• Able to interface with all levels and functions of the organization; requires a cooperative team-balanced perspective for appropriate output and task outcome.
• Experience working in regulated product and…