Advanced Sterilization Products, a division of Ethicon, Inc. is seeking a Staff Sustaining Engineer for our Irvine, California facility to provide ongoing engineering support as part of the overall Lifecycle Management on existing products, including capital terminal sterilization and high level disinfection equipment and hydrogen peroxide consumables used for terminal sterilization. Responsibilities will include: executing design changes within a Quality System compliant with FDA regulations on existing products to resolve existing Quality Issues; making proactive quality improvements; and making cost improvements. The position will own and execute product CAPA's (Corrective Action Preventative Action); conduct root cause investigation using six-sigma process or equivalent on existing quality issues; conduct Geometric and Dimension Tolerance analysis, tolerance stack-up analysis, free body diagrams, lead Design Reviews to create or update risk documentation and Product Design Requirements, develop and perform bench top tests, document design verification tests; write Design Change Plans; follow all the FDA regulations along with ASP procedures to ensure compliance. Additional responsibilities will include: Acting as the leader of a cross functional team which includes members from Research and Development, Product Quality, Regulatory, Sourcing, Planning, Manufacturing, and Marketing to ensure continuity of supply of product which meets all Johnson and Johnson quality standards and cost metrics. Working with a cross functional team to implement projects which proactively and reactively mitigate risks to quality and product supply; and mentoring Product Management Engineers, Contract Engineers, and Manufacturing Engineers in areas that include but are not limited to root cause analysis, reliability studies, design for manufacturing, and robust component validation & verification. Additional responsibilities also include managing teams of consulting engineers (contractors) both onsite in Irvine, California and stationed internationally
Position requires a minimum of a Bachelor of Science degree in Mechanical Engineering or a related field, and six years of experience in the regulated medical industry. Experience must include: performing Geometric Dimension and Tolerance analysis; stack-up analysis at an advanced level; identifying root cause of abstract problems; and sustaining engineering in medical devices. Must possess experience conducting and documenting engineering work and corresponding verification and validation in a manner that would be compliant according to Food and Drug Agency (FDA) regulations for medical devices, with specific experience in sterilization equipment (CFR Title 21, Parts 800 898). Experience with Six Sigma Process Excellence; Minitab 16; Reliasoft Weibull ++7; Solidworks 2015; Enventive 3.2.1; Mold Flow Analysis; Finite Element Analysis; and Good Manufacturing Practice FDA Requirements is also required. Experience with the following manufacturing methods are required: molding, machining, blow fill sealing, laser engraving, and sheet metal processing. Experience working with international suppliers is required. Up to 25% domestic and international travel is required.
To apply for this position, please submit your resume via email, indicating Requisition Code
3216161207 to: Paula Phelps at PPhelps@ITS.JNJ.com
Ethicon Inc. (6045)Job Function