Sr Manufacturing Mechanical Engineer - Shockwave

Role Summary

Sr Manufacturing Mechanical Engineer - Shockwave

Responsibilities

• 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.

Qualifications

• Bachelor‚Äôs degree on 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 SolidWorks 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 manufacturing environments (ISO, FDA, cGMP).
• Knowledge of and compliance with applicable Quality System requirements (e.g., traceability QSRs, ISO and MDD requirements.) and other applicable regulations.
• Experience in Program Management, use of Gantt Charts or Smartsheet.
• Proficiency in Statistics (Cpk, Hypothesis Testing, DOE, Gage R&R) a plus.
• Must be able to lift objects up to 25lbs.
• Must be able to travel abroad to oversee the implementation process and the qualification-validation efforts.

Education

• Bachelor‚Äôs degree in Mechanical Engineering or related field.