Senior Manufacturing Engineer

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

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JOB SUMMARY

This role supports manufacturing operations in the areas of process development, tool design, machine programming, machinery & equipment acquisition, manufacturing layout, continuous improvement and other duties associated with engineering support of production.

• Provides direction and technical support in identifying continuous improvements to manufacturing operations and implementing new technologies including development of processes, researching current and emerging technologies and evaluating process quality, cost, capacity and capability alternatives.
• Provides direction in supporting the needs of manufacturing areas in terms of meeting the requirements for quality standards and compliant documentation, capacity, product availability and cost.
• Provides direction and technical support regarding equipment design and development, testing of materials, preparation of specifications and operator instructions, process studies, investigations, root cause analysis, problem solving and report or presentation preparation.
• Performs assignments designed to continue the development of professional work knowledge and abilities requiring application of standard engineering techniques, procedures and criteria in carrying out a sequence of related engineering tasks, project management, statistical analysis and presentation of data and technical writing.  Mentors engineering staff.

DUTIES & RESPONSIBILITIES

In accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:

• Participates in multi-site projects.
• Leads and participates in complex engineering projects, either technically or with an extensive cross-functional team.  This includes developing and executing to the plan and schedule and meeting the goals and objectives of the project.  Tracks costs, prepares status reports, conducts meetings, and documents and communicates progress to management.   
• Leads and participates in investigations, develops plans and executes tasks to solve process problems including Nonconformances (NC), complaint investigations, audit observations and Corrective and Preventive Actions (CAPA).  Performs analysis and communicates associated trends.
• Provides day to day support and direction to production such as, but not limited to turning, milling, drilling, EDM, finishing, packaging etc. as required. 
• Develops process validation strategy and writes and executes engineering studies and process validation protocols and summary reports (Installation Qualification, Operation Qualification, Performance Qualification, Computer Software Validation and Test Method Validation).
• Identifies, leads and implements process improvements for existing manufacturing processes utilizing appropriate engineering principles and standard strategies such as, Lean and Six Sigma principles.
• Performs gage design, measurement system analysis, and gage implementation as required.  Is able to use various types of measuring instruments including, micrometers, calipers, comparators, tensile testers, coordinate measurement systems etc. to support engineering testing.
• Develops fixtures and designs tools and has the ability to express and implement ideas with tool designers.
• Leads new equipment acquisition efforts including user requirement specifications, machine selection, installation, validation, employee training, and other related equipment responsibilities as required.
• Develops and implements manufacturing and inspection procedures.
• Participates in and leads cross-functional teams which may include, but are not limited to Manufacturing Engineering, Production, Quality Assurance, Finance, Product Development and other sites.

• Acts as a liaison to vendors with regard to contracted products, tools & fixtures, and their manufacture.
• Identifies and implements improvements to engineering business processes such as configuration management, ERP management, maintenance tracking, etc.
• Performs other related duties, as required.

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• Responsible for communicating business related issues or opportunities to next management level
• Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.
• For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable
• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
• Performs other duties assigned as needed

EXPERIENCE AND EDUCATION

EXPERIENCE:

• 4-6 years of experience in manufacturing and/or engineering is required.
• Previous experience working in a regulated industry, such as Medical Device is preferred.
• Six Sigma or Lean Sigma certification or 4 years of experience preferred.
• Experience developing and implementing robust automated manufacturing equipment, preferred.
• Experience with packaging, Laser, and CNC processes and equipment, preferred

ESSENTIAL:

• Bachelor of Science Degree from accredited institution in Manufacturing Engineering, Mechanical Engineering, Industrial Engineering, or a related degree.
• Master of Science Degree from an accredited institution in Manufacturing Engineering, Mechanical Engineering, Industrial Engineering, or a related degree, preferred.
• Demonstrates working knowledge of machine and electrical safety standards, preferred.
• Demonstrates leadership qualities including confidence, transparency, integrity, innovation, passion, patience and tenacity.
• Demonstrates strong written, verbal and presentation skills.
• Demonstrates strong computer skills, such as the use of Microsoft Office, Minitab, and databases.  
• Demonstrates strong organizational and project management skills and are results oriented.
• Demonstrates positive interpersonal skills and professional interactions with coworkers.
• Demonstrates troubleshooting skills.

REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS

• Must be willing to support global projects including some travel.
• Must be willing to support all shifts.

• May be responsible for the supervision of Engineering Technicians or Interns.
• Participates in the hiring process for Engineering Technicians and Interns.
• Participates in and understands compliance related activities pertaining to the job assignment including compliance with the Quality System Regulation (QSR), Standard Operating Procedures (SOP), and applicable Work Instructions.

• Follows all laws and policies as they apply to one's job and maintains the highest levels of professionalism, ethics and compliance at all times.
• Supports and operates in a proactive safety environment

• Works in conditions that may be hot, cold, wet and/or noisy along with exposure to fumes, oil, coolants and other manufacturing related chemicals.