Johnson & Johnson companies are equal opportunity employers.
Senior Engineer-4804140221
Description
Mentor Worldwide, a member of the Medical Devices & Diagnostics Global Services, L.L.C., Global Supply Chain organization, within Johnson & Johnson's Family of Companies is recruiting for a Senior Engineer located in Irving, TX.
Medical Devices & Diagnostics (MD&D) Global Services, L.L.C., represents more than 60 manufacturing sites and 26,000 employees who plan, source, manufacture and deliver high-quality and cost-effective medical products to our customers around the globe each day. Work of the MD&D Supply Chain supports a multitude of product platforms, new products and delivery systems that are used in a wide range of procedures throughout the healthcare industry, including interventional cardiology, electrophysiology, minimally invasive surgery, hospital sterilization, clinical laboratory testing, diabetes management, joint replacement surgery and vision care.
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 Senior Engineer under the direction of the Manager, Plant Engineering, will manage most aspects of a project or initiative. This individual will be responsible for problem identification, root cause analysis, project management, financial analysis, project development, efficiency or productivity improvement and problem resolution. Interface directly with other facility and corporate functional groups to ensure that goals and objectives are met within GMP/ISO compliance and product design changes are addressed appropriately. Coordinate continuous improvement and productivity improvement activities on a business unit or plant level focused on Overall Equipment Effectiveness (OEE).
The Senior Engineer will manage and execute projects and/or programs of moderate to high level complexity ensuring safety, regulatory compliance, company standards, operation requirements and business needs are met. Provide project management guidance and business tools, utilizing a systematic approach to project execution. Prepare management reports and presentations. Ensure effective project planning and structure. Develop imaginative strategies for the efficient completion of projects. Set the engineering standard and direction for the group and is recognized as the source for guidance in a field. Lead the optimization of process output and throughput, equipment utilization, equipment downtime, waste reduction/yield improvements, budget management, standard cost and capital investment management in an innovative manner. Provide technical support to the production areas in evaluating process deficiencies, process changes, modifications and equipment failure. Define, analyze, review and evaluate problems for prompt solutions. Challenge the “status quo” on a routine basis and develop new ideas within incoming processes. Coordinate phases of work with other departments within the company and with other Ethicon divisions.
The Senior Engineer will provide technical support for non-conformance issues in the manufacturing area generating root cause analysis reports and corrective action identification (coordinates and participates on cross-functional investigations). Work on Non-Conformance Report (NCR) and Corrective Action/Preventative Action (CAPA) files from origination to full cycle completion and final approval as needed. Follow Standard Operating Procedures (SOPs), Good Manufacturing Practices (GMPs), company policies and federal, state and local government regulations. Revise and maintain engineering, equipment and process procedures. Participate in GMP audits regarding equipment recording and machine performance. Coordinate communications and interfaces with end users, machine manufacturers and/or suppliers. Participate in projects involving other departments and activities (CIM, QIP, CFM, etc.). Write, develop and implement validation procedures. Comply with Johnson & Johnson safety requirements and ensure safe working conditions and practices in the department. Review and analyze data, understanding of statistics and the application of statistical data, able to determine normal and non-normal data along with probable causes of non normal results.
Qualifications
A minimum of a Bachelor's degree in Engineering or a related discipline is required. A minimum of 4 years of related Engineering experience is required. Mechanical and or Process Engineering experience is preferred. Medical Device industry experience is preferred. Experience working in a manufacturing environment developing manufacturing standards is preferred. Experience developing validation procedures and protocols required. Experience in an automated manufacturing environment is preferred. Knowledge of Spray technologies preferred. Project management experience is preferred. Experience in a FDA regulated environment preferred. Knowledge of Good Manufacturing Practices (GMPs), ISO and/or other regulatory requirements preferred. Experience with Non-Conformance Reports (NCRs) and Corrective and Preventative Actions (CAPAs) preferred. Knowledge of risk assessments preferred. Knowledge of Microsoft Office (Word, Excel, PowerPoint, Outlook) is required. Experience with Microsoft Project is preferred. Experience with SolidWorks and AutoCAD preferred. Experience with Programmable Logic Controllers (PLCs) preferred. Knowledge of Process Excellence/Six Sigma tools and methodologies preferred. Process Excellence/Six Sigma (Green or Black Belt) Certification is preferred. Must have strong communication and interpersonal relation skills. Must have strong organizational skills. Must have the ability to prioritize multiple commitments and technical problem solving duties. Must have the ability to shift priorities according to changes in department/facility needs and open to different ideas/approaches. The ability to effectively present information and respond to questions from groups of managers, customers and other employees of the organization is required. The ability to collaborate with all levels of management in a cross-functional team environment is required. This position will require up to 15% domestic and international travel.
BE VITAL in your career. Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
Primary Location:North America-United States-Texas-Irving
Organization: Mentor Texas LP (6182)
Job Function: Engineering (Generalist)
Relocation: Eligible Yes - Within Country
Certain sites within the Johnson & Johnson Family of Companies participate in E-Verify as appropriate in accordance with Company guidelines and federal or state law. To learn more about the government sponsored program and to see a list of the sites that are currently enrolled, please click here.
Johnson and Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status, or any other characteristic protected by law.
EEO is the Law
EEO is the Law GINA Supplement
Senior Engineer-4804140221
Description
Mentor Worldwide, a member of the Medical Devices & Diagnostics Global Services, L.L.C., Global Supply Chain organization, within Johnson & Johnson's Family of Companies is recruiting for a Senior Engineer located in Irving, TX.
Medical Devices & Diagnostics (MD&D) Global Services, L.L.C., represents more than 60 manufacturing sites and 26,000 employees who plan, source, manufacture and deliver high-quality and cost-effective medical products to our customers around the globe each day. Work of the MD&D Supply Chain supports a multitude of product platforms, new products and delivery systems that are used in a wide range of procedures throughout the healthcare industry, including interventional cardiology, electrophysiology, minimally invasive surgery, hospital sterilization, clinical laboratory testing, diabetes management, joint replacement surgery and vision care.
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 Senior Engineer under the direction of the Manager, Plant Engineering, will manage most aspects of a project or initiative. This individual will be responsible for problem identification, root cause analysis, project management, financial analysis, project development, efficiency or productivity improvement and problem resolution. Interface directly with other facility and corporate functional groups to ensure that goals and objectives are met within GMP/ISO compliance and product design changes are addressed appropriately. Coordinate continuous improvement and productivity improvement activities on a business unit or plant level focused on Overall Equipment Effectiveness (OEE).
The Senior Engineer will manage and execute projects and/or programs of moderate to high level complexity ensuring safety, regulatory compliance, company standards, operation requirements and business needs are met. Provide project management guidance and business tools, utilizing a systematic approach to project execution. Prepare management reports and presentations. Ensure effective project planning and structure. Develop imaginative strategies for the efficient completion of projects. Set the engineering standard and direction for the group and is recognized as the source for guidance in a field. Lead the optimization of process output and throughput, equipment utilization, equipment downtime, waste reduction/yield improvements, budget management, standard cost and capital investment management in an innovative manner. Provide technical support to the production areas in evaluating process deficiencies, process changes, modifications and equipment failure. Define, analyze, review and evaluate problems for prompt solutions. Challenge the “status quo” on a routine basis and develop new ideas within incoming processes. Coordinate phases of work with other departments within the company and with other Ethicon divisions.
The Senior Engineer will provide technical support for non-conformance issues in the manufacturing area generating root cause analysis reports and corrective action identification (coordinates and participates on cross-functional investigations). Work on Non-Conformance Report (NCR) and Corrective Action/Preventative Action (CAPA) files from origination to full cycle completion and final approval as needed. Follow Standard Operating Procedures (SOPs), Good Manufacturing Practices (GMPs), company policies and federal, state and local government regulations. Revise and maintain engineering, equipment and process procedures. Participate in GMP audits regarding equipment recording and machine performance. Coordinate communications and interfaces with end users, machine manufacturers and/or suppliers. Participate in projects involving other departments and activities (CIM, QIP, CFM, etc.). Write, develop and implement validation procedures. Comply with Johnson & Johnson safety requirements and ensure safe working conditions and practices in the department. Review and analyze data, understanding of statistics and the application of statistical data, able to determine normal and non-normal data along with probable causes of non normal results.
Qualifications
A minimum of a Bachelor's degree in Engineering or a related discipline is required. A minimum of 4 years of related Engineering experience is required. Mechanical and or Process Engineering experience is preferred. Medical Device industry experience is preferred. Experience working in a manufacturing environment developing manufacturing standards is preferred. Experience developing validation procedures and protocols required. Experience in an automated manufacturing environment is preferred. Knowledge of Spray technologies preferred. Project management experience is preferred. Experience in a FDA regulated environment preferred. Knowledge of Good Manufacturing Practices (GMPs), ISO and/or other regulatory requirements preferred. Experience with Non-Conformance Reports (NCRs) and Corrective and Preventative Actions (CAPAs) preferred. Knowledge of risk assessments preferred. Knowledge of Microsoft Office (Word, Excel, PowerPoint, Outlook) is required. Experience with Microsoft Project is preferred. Experience with SolidWorks and AutoCAD preferred. Experience with Programmable Logic Controllers (PLCs) preferred. Knowledge of Process Excellence/Six Sigma tools and methodologies preferred. Process Excellence/Six Sigma (Green or Black Belt) Certification is preferred. Must have strong communication and interpersonal relation skills. Must have strong organizational skills. Must have the ability to prioritize multiple commitments and technical problem solving duties. Must have the ability to shift priorities according to changes in department/facility needs and open to different ideas/approaches. The ability to effectively present information and respond to questions from groups of managers, customers and other employees of the organization is required. The ability to collaborate with all levels of management in a cross-functional team environment is required. This position will require up to 15% domestic and international travel.
BE VITAL in your career. Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
Primary Location:North America-United States-Texas-Irving
Organization: Mentor Texas LP (6182)
Job Function: Engineering (Generalist)
Relocation: Eligible Yes - Within Country
Certain sites within the Johnson & Johnson Family of Companies participate in E-Verify as appropriate in accordance with Company guidelines and federal or state law. To learn more about the government sponsored program and to see a list of the sites that are currently enrolled, please click here.
Johnson and Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status, or any other characteristic protected by law.
EEO is the Law
EEO is the Law GINA Supplement