J&J Family of Companies Staff (IV) Manufacturing Engineer, Asset Reliability in Monument, Colorado
DePuy Synthes, Inc, part of the Global Orthopeadics Group within Johnson & Johnson Medical Devices is recruiting for a Staff (IV) Manufacturing Engineer, Asset Reliability in Monument, CO.
DePuy Synthes Companies of Johnson & Johnson is the largest, most innovative and comprehensive orthopaedic and neurological business in the world. DePuy Synthes Companies offer an unparalleled breadth and depth of products, services and programs in the areas of joint reconstruction, trauma, spine, sports medicine, neurological, craniomaxillofacial, power tools and biomaterials. Building on the legacy and strengths of two great companies, more agile and better equipped to meet the needs of today’s evolving health care environment. With a focus on activating insights to develop innovative, comprehensive solutions, we are inspired to advance patient care in greater ways than either company could accomplish on its own.
This position will be responsible for developing and maintaining our asset management and reliability program including reporting on Mean Time Between Failure (MTBF), Mean Time to Repair (MTTR) and data to facilitate continuous improvement. This position will ensure integrity of our spare parts and preventive maintenance programs as well as facilitate asset criticality and risk assessments. In addition, this position will manage the layout of the assets, manage scheduled facility shut-downs and track asset depreciation and disposal.
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. Provides technical support and direction across the site and mentors engineering staff.
Staff (IV) Manufacturing Engineers are also responsible as follows:
Identifies, recommends and implements transformational process opportunities within and across sites. Leads or participates in such projects.
Identifies, recommends and implements standardization of processes across the business.
Leads and participates in highly 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.
Identifies, leads and implements transformational process improvements for existing manufacturing processes utilizing appropriate engineering principles and standard strategies such as, Lean and Six Sigma principles.
Participates in and leads cross-functional teams which may include, but are not limited to Manufacturing Engineering, Production, Quality Assurance, Finance, Product Development, personnel from other sites and external resources.
Leads and participates in complex 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.
Participates or leads internal or external technical committees in the development of standards related to manufacturing such as processes, DFMA, equipment, testing.
May be responsible for the supervision of Engineering Technicians, Interns or Contractors.
Participate in the hiring process for Engineering Technicians and Interns.
Participate in and understand 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.
As required, the STAFF (IV) Manufacturing Engineer may:
Provide day to day support and direction to production such as, but not limited to turning, milling, drilling, EDM, finishing, packaging etc.
Develop process validation strategy for complex processes and write and execute engineering studies and process validation protocols and summary reports (Installation Qualification, Operation Qualification, Performance Qualification, Computer Software Validation and Test Method Validation).
Develop strategy for 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.
Develop strategy for fixtures and tool design and can express and implement ideas with tool designers.
Lead new equipment acquisition efforts including user requirement specifications, machine selection, installation, validation, employee training, and other related equipment responsibilities as required.
Develop and implement manufacturing and inspection procedures.
Act as a liaison to vendors about contracted products, tools & fixtures, and their manufacture.
Identify and implement improvements to engineering business processes such as configuration management, ERP management, maintenance tracking, etc.
Perform other related duties, as required.
Bachelor of Science Degree from accredited institution in Manufacturing Engineering, Mechanical Engineering, Industrial Engineering, or a related degree is required.
Master of Science Degree from an accredited institution in Manufacturing Engineering, Mechanical Engineering, Industrial Engineering, or a related degree, preferred.
A minimum of 6 years of experience in manufacturing and/or engineering is required.
Previous asset reliability experience is required.
Experience leading plant shut-down activities 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.
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 skill is required.
Demonstrates strong computer skills, such as the use of Microsoft Office, Minitab, and databases is required.
Demonstrates strong organizational and project management skills and are results oriented is required.
Demonstrates positive interpersonal skills and professional interactions with coworkers.
Demonstrates troubleshooting skills.
Must be willing to support global projects including some travel up to 10%.
This is a first shift position but must be willing to support all production shifts is required.
This position is located in Monument, CO.
DePuySynthes Products Inc (6149)