Ethicon, a member of Johnson & Johnson Family of Companies, is recruiting for a System Engineer located in San Angelo, TX
The Ethicon business offers a broad range of products, platforms and technologies-including sutures, topical skin adhesives, hemostasis products, surgical staplers, trocars, energy devices and synthetic mesh devices-used in a wide variety of open and minimally invasive surgical procedures. Specialties include orthopedics, support for treatment of colorectal and thoracic conditions, women's health conditions, hernias, cancer and obesity.
he Ethicon business combines products and services of two market leading legacy companies, both with long histories of medical innovation. Ethicon, Inc. based in Somerville, New Jersey, was founded more than 80 years ago as a pioneer in suture development and manufacturing, helping to transform the safety and effectiveness of surgery. Ethicon Endo-Surgery, Inc., based in Cincinnati, Ohio, was founded 20 years ago to develop innovative devices that have driven the groundbreaking shift from open to minimally invasive surgery that continues to lead the industry today.
System Engineer will be responsible for applying extensive and diversified knowledge of electronic principles and practices in a broad range of assignments and related fields. Makes decisions regarding engineering problems and methods and represents the company in conferences to solve problems and to plan and coordinate work. Responsible for the engineering and quality assurance of part of a major project or for a complete small project
Act as plant’s Manufacturing Execution System (MES) Manager
Lead Site Manufacturing Execution System (MES) Journey by overseeing improvements and administration of MES software.
Lead engineering projects ensuring that projects are completed on schedule and within budget.
Develop, lead and execute detailed project plans that will lead to improve performance using standard project management tools (charter, Gantt charts, etc.).
Prepare/review capital & expense forecasts for assigned projects.
Prepare capital appropriation requests (CAR)with cost justification for projects.
Prepare diagrams, charts, drawings, calculations, and presentations. S/he translates relevant data/information into broadly understandable terms to convey risks and provide the means by which project trade off discussions and decisions may be made
Report status on assigned projects in various formats to various organizational levels.
Ensure effective and efficient use of Project Engineering tools (Six Sigma/Lean Mfg) and techniques to solve opportunities.
Manage the Non-Conformance (NC) and Corrective and Preventive Action (CAPA) process by documenting, investigating, conducting root cause analysis, and implementing corrective actions for product non-conformances.
Ensure effective engineering and quality systems and adherence to Quality System Regulations (QSR).
Learn and follow the Ethicon design control process to all applicable projects. This is a strict change control process that governs the MES software to ensure system is maintained under control and re-tested as required to maintain validated state.
Perform process validations on new, transferred or modified processes for MES implementation.
Ensure compliance to the quality policy in all activities.
Support and promote the safety and industrial hygiene objective of the plant.
Lead cross functional teams during investigations for MES Continuous Improvements.
Responsible for supervising MES technicians in the Manufacturing Execution System.
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 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
Qualifications & Requirements
Minimum of four () years of relevant work experience
In depth knowledge of FDA guidelines pertaining to software validation (or comparable regulatory compliance knowledge)
Knowledge of Software Systems
Knowledge in 21 CFR Part 11 compliance or comparable data security experience
Knowledge of Microsoft Office (Word, Excel, PowerPoint, Outlook)
Strong Computer Science technical background
Knowledge in specific systems (Siemens CAMSTAR Manufacturing Execution System) and technical standards, business hardware/software/network fundamentals and query and reporting tools (SQL, TOAD, etc.)
Project management skills and influencing skills
Results oriented and follow up skills
Communication, engagement, and problems solving skills
Ability to read analyze and interpret general business documents
At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through innovative programs and policies, we empower the physical, mental, emotional and financial health of our employees and the ones they love. As such, candidates offered employment must show proof of COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.