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At Johnson & Johnson Medical Devices Companies, we are using our breadth, scale, and experience to reimagine the way healthcare is delivered and to help people live longer, healthier lives.
In a radically changing environment, we are making connections across science and technology to combine our own expertise in surgery, orthopedics, and interventional solutions with the big ideas of others to design and deliver doctor and patient-centric products and solutions.
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Please visit https://www.jnjmedicaldevices.com/es-419 for more information.
Ethicon Endo-Surgery develops and markets advanced medical devices for minimally invasive and open surgical procedures, focusing on procedure-enabling devices for the interventional diagnosis and treatment of conditions in general and bariatric surgery, as well as gastrointestinal health, gynecology, and surgical oncology. For more information, visit www.ethiconendosurgery.com
The Principal External Manufacturing Engineer will contribute to or lead development, design, and the validation of existing and start-up manufacturing / assembly operations that meet objectives for product quality, cost, and performance. Participate in all other team activities contributing where required to other functional areas within team. Ensure product is properly designed for manufacture and that manufacturers are properly selected and qualified. Assignments will typically be of low to moderate size and complexity, or he/she may be assigned responsibility for part of a more complex project. Interface with Manufacturers and EES groups to ensure design for manufacturability, quality, and cost goals are met. Assist by providing technical support to evaluate and select manufacturers. Provide technical support to assist in establishing and maintaining GMP compliant processes. Perform engineering studies and analyses on existing manufacturing processes to improve process reliability, problem solve, or to improve product quality and cost. Design and/or purchase tooling and equipment. Using appropriate statistical techniques, develop validation protocols, complete process capability studies, and process validations on both internal and supplier processes. Actively participate in other team activities to help ensure total team success. Take an active role in learning for self and others to further the company objectives. Complete assignments
Responsabilities:
- Provide line support responsibilities for specific products. Coordinate technical and/or business issues with internal and external customers (typical scope is at a business unit level).
- Act as an ISO Champion or Deputy for EES Quality System(s), as required.
- Apply comprehensive and diverse knowledge of engineering / business principles to a broad range of assignments. Plan, conduct, and direct engineering / business projects to completion (typical scope is at business unit and/or External Manufacturing level).
- Coordinate and direct activities of other technical support staff and delegate their assignments, as required. Devise or adapt new methods, using a full understanding of procedures and various product support improvement techniques.
- No direct reports. Up to 25% travel, including international. Some travel may be on short notice.
Qualifications
- To meet requirements, a Bachelor of Science Degree in Electrical/ Electro-Mechanical / Mechatronic Engineering or other scientific discipline with Engineering experience.
- Minimum of 8 years of related manufacturing engineering experience; or an advanced degree (e.g., M.S.) with 6 years of related manufacturing engineering experience.
- Previous experience in printed circuit board assembly and testing is preferred. Knowledge of regulatory affairs, GMP (Good Manufacturing Practices) and ISO9000 (International Organization for Standardization) is highly preferred.
- Medical device experience is highly preferred. Manufacturing/assembly experience is required. Experience with Process Development and Design; Materials Manufacturing and Processing; Injection molding; Elastomeric and Electronic Components; Ultrasonic Device Development; Mechanical and/or Electro-mechanical assemblies is preferred.
- Experience with process validation, statistical process control, and knowledge in applied statistics is preferred. CAD or other 3D modeling experience is preferred
