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Process Engineering Manager
Los Gatos, California
Requisition ID: 9464171220
Johnson & Johnson’s Cardiovascular & Specialty Solutions (CSS) Group within Medical Devices is recruiting for a Process Engineering Manager for Cerenovus located in Los Gatos, CA . The CSS Group serves a diverse base of customers in Ear, Nose and Throat (ENT), Infection Prevention, Electrophysiology (EP), Neurovascular, Surgical and Non-Surgical Aesthetics, and Reprocessing.
Cerenovus, part of the Johnson & Johnson Medical Devices Companies, is a global leader in neurovascular care. Our commitment to changing the trajectory of stroke is inspired by our long heritage and dedication to helping physicians protect people from a lifetime of hardship. Cerenovus offers a broad portfolio of devices used in the endovascular treatment of hemorrhagic and ischemic stroke.
• Prioritize the work of Manufacturing Engineering department to have the greatest positive impact on the quality, cycle time, and cost of the product(s)
• Be responsible for all assembly operations development, and interface with R&D for DfX (Design for Manufacturability/ Cost/ Excellence) implementations
• Proficient with the current Good Manufacturing Practice cGMP/QSR requirement, and ISO 13485
• Write and execute protocols for process testing and validations
• Be proficient in process, tooling, & documentation design and development
• Be responsible for the implementation of process fixtures and equipment
• Work with R&D, and QA to improve manufacturing processes, designs, inspection methods and documentation.
• Direct the manufacturing process development, validation and inspection
• Evaluate, monitor and review existing resources and identifying resource gaps
• Provide updates, and presentations to sr. management on production efficiencies and status of projects
• Coach, manage and develop employees within the reporting structure
• Support other departments from time to time as required (clinical, sales, marketing, etc)
• A minimum of a Bachelor’s Degree in Engineering is required, an advanced degree is preferred
• A minimum of eight (8) years of relevant regulated industry experience is required
• A minimum of three (3) years of management experience is required
• Demonstrated experience in Medical Device industry is preferred
• Proficient with DOE, and statistical techniques as it relates to data analysis and process control is required
• Familiarity with clinical use, design, and manufacturing of neurovascular implants is preferred
• Familiarity with processes, materials, and regulations associated with neurovascular implant manufacturing is preferred
• Familiarity with various metrology methods used in medical device manufacturing & inspection; e.g. calipers, micrometers, optical scopes is preferred
• Must be proficient with a standard business software suite operating on a PC e.g. MS Outlook, MS Word, MS Excel, Powerpoint, etc., is required
• Must be proficient using CAD software such as Pro/E or Solidworks is required
• Ability to travel up to 10% of the time is required
United States-California-Los Gatos
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