Staff Manufacturing Engineer - Shockwave

Johnson & Johnson is hiring for a Staff Manufacturing Engineer, Shockwave Medical to join our team located in Santa Clara, CA
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The Staff Manufacturing Engineer is responsible for designing, developing, testing, documenting, and implementing processes, tooling, and fixtures throughout the product lifecycle, from design to production. The Staff Manufacturing Engineer will work closely with production, quality, and R&D teams to support the company’s manufacturing operations and product launch timelines.

• Work collaboratively with R&D, QA, and Production departments to design, develop, test, document and implement processes, tooling, and fixtures.
• Collect data and analyze process performance and capabilities for company products, including new products and products already in production.
• Perform tolerance analysis for components, manufacturing materials, packaging, and supplies used for in-house processing.
• Lead effort to develop and maintain process Failure Modes and Effects Analyses (pFMEAs) for company processes.
• Prepare user requirements, technical specifications, and design specifications.
• Identify process requirements, advise and support operations management, and implement equipment and fixturing needed for process development and manufacturing efforts.
• Develop and maintain documentation for design control, product configurations, manufacturing procedures, lot history records (e.g., bills-of-materials, MPIs, LHRs), and other Quality System requirements.
• Evaluate existing engineering processes and implement process improvements.
• Lead and/or actively participate in product/process engineering problem solving using DMAIC methodology.
• Lead and/or actively participate in process/product improvement projects (in cooperation with production, R&D engineers and technicians).
• Assist Procurement and R&D departments with supplier selection and technical development.
• Recommend new technologies to improve system performance and reliability. Performs productivity and costing analyses (e.g., calculate direct labor, time studies & materials costs for new and existing products), providing solutions that improve efficiency and scalability for years to come.
• Identify opportunities and implement cost reduction plans for existing products.
• Support the transfer of product lines and the qualification-validation efforts.
• Other duties as assigned. These job requirements are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel.

• Bachelor s degree in Mechanical or Biomedical Engineering.
• Minimum of eight (8) years of experience in a medical device environment or equivalent experience in other industries (pharmaceutical or automotive) that use the same principles of operation and similar regulations, or 6 years of experience with a Master s Degree.
• Knowledge of and compliance with applicable Quality System requirements such as QSRs, FDA, ISO, MDD and other applicable regulations.
• Experience and understanding of Process Validations (IQ, OQ, PQ), 6S, Lean Manufacturing.
• Experience applying statistics and using statistical software, running Capability Studies (Cpk s), and planning and analyzing DOE s.
• Demonstrated proficiency in written and verbal communication, including creating and delivering presentations.
• Ability to use special software such as Solidworks, Minitab or closely related.
• Ability to work in a fast-pace ronment while managing multiple priorities.
• Operate as a team and/or independently while demonstrating flexibility to changing requirements.
• Employee may be required to occasionally lift objects up to 25 lbs.

• The anticipated base pay range for this position is $105,000 to $169,050 annually.
• The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation s performance over a…