Johnson & Johnson

Manufacturing Engineer

  • Experience 0-5 Years
  • Category Engineering
  • Location Irving, TX

Job Description

Mentor Worldwide, a member of Johnson & Johnson's Family of Companies is recruiting for a Manufacturing Engineer, located in Irving, TX.

Mentor is a trusted global leader in aesthetic medicine among both consumers and clinicians by providing a broad range of innovative, science and clinical-based solutions to maintain, enhance, and restore self-esteem and quality of life.  The company has products and services in three areas of aesthetics:  breast (augmentation and reconstruction), body and face.


The Manufacturing Engineer is responsible for:

• Identifying, justifying, developing and implementing process improvements and new equipment systems and/or upgrading existing processes and equipment in order to increase product quality, operator safety and process productivity by applying Six Sigma and Lean Manufacturing Methodologies. 
• Providing support for evaluating and analyzing relevant process information and monitoring vital aspects of process control to allow for reporting of Operations KPIs such as manufacturing quality and productivity performance, as part of Business Unite Performance Review. 
• Developing and implements process elements of the Quality Management System (QMS) such as Management Controls, Design Controls, Production and Process Controls (P&PC) and Corrective/Preventive Actions (CAPA) for a Medical Device Industry according to USA Food and Drug Administration (FDA) requirements.
• Using problem solving techniques to troubleshoot process variations that generate favorable variances in yield, material and/or labor to assist assigned production support areas.
• Applies Process Failure Mode and Effects Analysis (PFMEA), Statistical Process Control (SPC), Mistake Proofing and Root Cause Analysis methodologies to ensure robust design and/or data analysis throughout each stage of design, development and implementation of products and processes. 
• Participating on cross-functional new product and/or process development teams and ensures a capable process for transferring manufacture of new products to production by developing and executing Process Capabilities and Characterization Studies.
• Reviews, performs bounding, depositions and identify the root cause(s) of non-conformant product through the Non-Conformance (NCR), Corrective Action and Preventive Action (CAPA) as well as Risk Assessment process.
• Participating in Internal Audits of Manufacturing Processes and Gap Analysis of company’s Quality Management Systems (QMS) in order to align company’s existing Process Control and Quality Management Systems (QMS) to US Food and Drug Administration (USFDA) requirements as they are stated in Quality System Regulations (QSR) 21 CFR Part 820.
• Developing documentation and conducts Equipment Installation Qualification (IQ), Operation Qualification (OQ), Process Performance Qualifications (PPQ), Gauge Repeatability and Reproducibility (Gage R&R) and as well as Process Validations (PV), Software Validations (SV) and Test Method Validations (TMV).
• Developing and implements Work Instructions (WIs) and Standard Operating Procedures (SOP) through the Change Order (CO) process, while maintains compliance with the current Good Manufacturing Practices (cGMPs), Federal, State and Local Government Regulations



• A minimum of a Bachelor’s Degree in an Engineering discipline
• An advanced degree is preferred
• A minimum of three (3) years of relevant experience 
• Experience in IQ, OQ, PQ is required
• Experience identifying root cause analysis is required
• Experience working with CAPA’s is required
• Knowledge of key regulations and standards such as: Quality System Regulations (QSR) 21 CFR Part 820, ISO13485 and 21CFR820 is required

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