SENIOR PROCESS ENGINEER Orthopedics

Position Overview

Sr. Process Engineer – Fixed Term 12 Months – Juarez City, Chihuahua, Mexico. The role focuses on project planning, execution, and technical oversight within a medical device manufacturing environment. Upon completion of the DePuy Synthes transaction, the employee may transition to that entity.

Responsibilities

• Develop project objectives and plans in conjunction with management; execute detailed plans using standard project management tools (charter, Gantt chart, etc.).
• Determine project schedules by analyzing plans, specifications, product design, customer requirements, and performance standards; calculate time requirements, sequence elements, complete technical studies, and prepare cost estimates.
• Control and maintain project plans, schedules, and budgets; monitor progress and adjust as needed.
• Plan and schedule project changes; coordinate activities, recommend actions, and resolve problems.
• Oversee and coordinate technical aspects of the project through coordination meetings and other communications.
• Approve and plan expenditures; maintain accurate records of all project elements.
• Prepare and present status reports at various organizational levels; analyze and summarize trends, recommend actions.
• Follow the Ethicon change control process for all applicable projects.
• Confirm product performance through design and conduct of tests; perform process validation on new, transferred, or modified processes.
• Prepare/review capital and expense forecasts and prepare capital authorization requests (CAR).
• Control project costs by approving and monitoring expenditures; administer contractor contracts.
• Maintain project integrity and reputation via compliance with state, federal, and company regulations.
• Ensure personal and company compliance with all applicable regulations, policies, and procedures.
• Ensure effective use of engineering and quality systems and adherence to QSR (Quality System Regulations).
• Manage the NCR and CAPA process: document, investigate, conduct root cause analysis, and implement corrective actions for product non‑conformances.
• Maintain a safe and clean working environment by enforcing procedures, rules, and regulations.
• Ensure compliance with OSHA and J&J machine guarding requirements.
• Support the safety and industrial hygiene objectives of the plant.

Qualifications & Requirements

• 4 to 6 years of experience in manufacturing or design engineering.
• B.S. Engineering Degree or equivalent science discipline knowledge.
• Six Sigma Green or Black certification.
• Statistical analysis skills – GR&R, process capability, Minitab, DOEs, etc.
• Ability to read and understand engineering documentation and blueprints.
• Experience with manual and automated assembly equipment and processes.
• Strong analytical and problem‑solving abilities.
• Knowledge of calibration production costs and ERP systems (SAP, JD Edwards, E‑1).
• Experience with risk assessment tools (PFMEA, DFMEA) and product control procedures.
• Understanding of design and production cost factors including waste, downtime, scrap, and re‑work.
• Knowledge of calibration concepts and measurement systems.
• Understanding of international customs procedures.
• Experience with medical device regulatory requirements: MDD, ISO 13485, FDA design controls or equivalent.
• Experience on medical device (ClassII or ClassIII) projects.

Preferred Skills

• Accelerated project management, analytical reasoning, coaching, and communication.
• Facility management, GMP, Lean manufacturing principles, and lean supply chain management.
• Manufacturing engineering, MSAT, problem management, project engineering, and report writing.
• Safety‑oriented mindset and STEM proficiency.
• Technologically savvy and familiarity with industry‑specific tools.