STAFF PROCESS 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.
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Diversity, Equity & Inclusion are essential to continue building our history of pioneering and innovation, which has been impacting the health of more than 1 billion patients and consumers every day for more than 130 years.
Regardless of your race, belief, sexual orientation, religion, or any other trait, YOU are welcome in all open positions at the largest healthcare company in the world.   When You Join Johnson & Johnson, Your Move Could Mean Our Next Breakthrough.
We are searching for the best talent for Staff Process Engineer to be in Cd.
Juarez, Chih.
Planta Independencia Purpose.
Completes engineering projects by organizing and controlling project elements and is responsible for all engineering and technical disciplines that projects involve.
The project engineer will schedule, plan, forecast, resource and manage all the technical activities aiming at assuring project accuracy and quality from conception to completion.
You will be responsible for.
Under general supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position responsibilities may include, but are not limited to.
Lead engineering projects ensuring that projects are completed on time and within budget with no impact to quality or customer service.
Develop project objectives and project plans conferring with management and executes detailed project plans using standard project management tools (charter, Gantt chart, etc).
Determines project schedule by studying project plan and specifications, product design, customer requirements and product performance standards; calculating time requirements; sequencing project elements, completing technical studies and preparing cost estimates Controls and maintains project plan and schedule by reviewing design, specifications and monitoring project progress, and project budget.
Plans and schedules project changes; coordinating activities; recommending actions and resolving problems.
Through project coordination meetings and other forms of communication, oversees and coordinates the technical aspects of the project.
Approves and plans expenditures; and keeps an accurate record of all elements of the project Prepares and presents project status reports in formats adequate to different organizational levels by collecting, analyzing, and summarizing information and trends; recommending actions Follows the Ethicon change control process for all applicable projects.
Confirms product performance by designing and conducting tests and performs process validation on new, transferred or modified processes Prepares/reviews capital & expense forecasts for assigned projects.
Prepares capital authorization requests (CAR).
Controls project costs by approving and monitoring expenditures; administering contractor contracts.
Maintains project integrity and reputation through compliance with state and federal regulations.
Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures Ensures effective use of engineering and quality systems and adherence to quality system regulations (QSR).
Ensures compliance to the quality policy in all activities.
Manages the NCR and CAPA process by documenting, investigating, root cause analysis, and implementing corrective actions for product non-conformances.  Maintains safe and clean working environment by enforcing procedures, rules, and regulations.
Ensures all OSHA and J &J Machine Guarding requirements are met.
Supports and promote the safety and industrial hygiene objective of the plant Responsible for communicating business related issues or opportunities to next management level Other responsibilities may be assigned and not all responsibilities listed may be required.
Responsible for communicating business related issues or opportunities to next management level For those who supervise or manage a staff, responsible for ensuring that subordinates follow al 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 Qualifications External  Qualifications.
B.
Engineering Degree or Science Discipline An advanced degree, such as an MS or an MBA is preferred.
Project Management and strong crossfunctional business experience.
6 to 8 years experience in manufacturing/design engineering  Six Sigma Green or Black Certification and/or other project management methodology is preferred Able to read and understand engineering drawings and translate product drawings into process information Hands on experience with manual and automation assembly equipment and/or processes Position requires excellent organizational and communication skills (written and oral, fluent in English) plus the ability to function/lead in a team-based manufacturing environment.
Ability to make and manage good relationships Presentation skills Able to make decisions Demonstrates strong negotiating and influencing Skills.
Analytical and problem-solving skills Initiative and results/target focused Experience in Bill of Material (BOM) structures An understanding of Lean Manufacturing and lean principles with an ability to promote and drive continuous improvement Understanding of design and production costs to include waste, downtime, scrap and re-work Understanding of calibration concepts and Measurement systems.
Understanding of International customs procedures.
 Experience with the essential requirements of the Medical Device Directive (MDD), ISO , FDA design controls or similar regulatory environment in design control and process validation Experience on medical device (Class II or Class III) projects.
Experience utilizing enterprise resource planning (ERP) tools.
Experience in project management, Understanding of customer expectations and deliverables with an awareness of the impact of failure/cost of poor quality