Senior Process Engineer Orthopedics

Johnson & Johnson Johnson & Johnson · Pharma · Juarez, Chihuahua, Mexico

Senior Process Engineer for Orthopedics at Johnson & Johnson in Juarez, Mexico. This role focuses on developing and executing project plans, managing project schedules and budgets, ensuring compliance with regulations (FDA, ISO 13485), and implementing quality systems like NCR and CAPA. Requires experience in manufacturing/design engineering, Six Sigma, statistical analysis, and medical device regulations.

What you'd actually do

  1. Develop project objectives and project plans conferring with management and executes detailed project plans using standard project management tools (charter, Gantt chart, etc).
  2. 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
  3. Controls and maintains project plan and schedule by reviewing design, specifications and monitoring project progress, and project budget.
  4. Plans and schedules project changes; coordinating activities; recommending actions and resolving problems.
  5. Through project coordination meetings and other forms of communication, oversees and coordinates the technical aspects of the project.

Skills

Required

  • 4 to 6 years experience in manufacturing/design engineering
  • B.S Engineering Degree or Science Discipline
  • Knowledge Six Sigma Green or Black Certification
  • Statistical analysis – GR&R, Process Capability, (Six pack tools – Minitab), DOEs, etc.
  • Able to read and understand engineering documentations and blueprints
  • experience with manual and automation assembly equipment and/or processes
  • Analytical and problem-solving skills
  • Calibration
  • Production costs
  • ERP – Enterprise Resource and Planning - (SAP – JD Edwards – E-1).
  • Risk assessment tools (PFMEA-DFMEA) and PCP
  • 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 13485, FDA design controls or similar regulatory environment in design control and process validation
  • Experience on medical device (Class II or Class III) projects.

Nice to have

  • Lean Manufacturing Principles
  • Lean Supply Chain
  • Good Manufacturing Practices (GMP)
  • Analytical Reasoning
  • Coaching
  • Communication
  • Facility Management

What the JD emphasized

  • compliance with state and federal regulations
  • quality system regulations (QSR)
  • Medical Device Directive (MDD), ISO 13485, FDA design controls