Manufacturing New Product Introduction (NPI) Engineer

Company: Disability Solutions
Location: Santa Clara
Posted on: September 15, 2023

Job Description:

The Robotic And Digital Solutions group, part of the Ethicon Medical Devices sector within Johnson & Johnson, is recruiting for a Manufacturing New Product Introduction (NPI) Engineer located in Santa Clara, CA . Johnson & Johnson Medical Devices is focused on shaping the future of digital surgery and expanding its robotics and digital solutions offerings across the entire portfolio, with multi-specialty, end-to-end solutions in orthopedics, endoluminal intervention, and general surgery. This includes the MONARCH-- platform, a first-of-its-kind robotic technology indicated for bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedures in the lung. Ethicon, part of Johnson & Johnson Medical Devices Companies, has made significant contributions to surgery for more than 100 years from creating the first sutures to revolutionizing surgery with minimally invasive procedures. Our continuing dedication to Shaping the Future of Surgery is built on our commitment to help address the world's most pressing healthcare issues and improve and save more lives. Through Ethicon's surgical technologies and solutions including sutures, staplers, energy devices, trocars and hemostats, and our commitment to treating serious medical conditions like obesity worldwide, we deliver innovation to make a life-changing impact. For more information, visit . The Manufacturing NPI Engineer is responsible for acting as a team member on process development projects conducting various assignments in cooperation with direction of team & team leader. Scope of responsibility included specifying, procuring, qualifying, validating, troubleshooting, and maintaining equipment and process needed for robotic assembly, dispensing, and/or packaging components and/or products. Developing components and assemblies for processing. Supports investigations to determine root cause of failures, presents results, and proposes corrective and preventative actions as required. Uses capabilities, such as Lean/Six Sigma, DFx, SPC, etc, to improve company knowledge, products and processes. Collaborates and interacts with other company engineering teams, including teams representing R&D, Product Quality, Regulatory, and Supplier Quality. Provide engineering, risk assessment, and statistics support in the development and maintenance of the company's quality systems. Follows domestic and international regulatory standards (e.g., GMP and ISO 13485). Responsibilities:

• Works under general supervision.
• Develop components, boards, and assemblies using DFx, GD&T, etc
• Develop process windows/limits for manual and automated production processes.
• Perform process validations as required, IQ/OQ/PQ; generate protocols and test reports.
• Act as technical liaison between R&D Engineering and Manufacturing.
• Complete engineering assignments involving design, development, testing.
• Learns and maintains methods for inspecting, testing, and evaluating complaint-related product.
• Design, develop, and improve manufacturing processes, equipment, and tooling.
• Understands and applies test methods to locate, reproduce, identify, and analyze complex failures. Develop Process Failure Mode and Effects Analyses.
• Apply comprehensive & and diverse knowledge of engineering principles to assignments.
• Coordinate activities with internal & and external customers and suppliers.
• Authors and reviews technical protocols, reports, standards and change orders.
• Participates in the presentation of progress and results to all levels of organization.
• Generates monthly status reports on individual activity.

Keywords: Disability Solutions, Santa Clara , Manufacturing New Product Introduction (NPI) Engineer, Engineering , Santa Clara, California