EDI Staff Engineer

Job Title

BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it's no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of Med Tech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.

Responsibilities:

Develops Strategies, Collaborates and Communicates with:

• Product Design Team:
  Support manufacturable product designs aligned with cost and quality targets.
• Unit and Plant Quality Teams:
  Support compliance with regulatory, GMP, ISO, and validation requirements.
• Production Teams:
  Ensure equipment is operable, reliable, and capable of meeting production targets.
• Maintenance / Engineering Teams:
  Support uptime, maintainability, and troubleshooting readiness.
• Procurement & Vendors:
  Support sourcing, supplier technical alignment, and execution milestones.
• Plant Quality Team: to ensure that equip. is operating within specified tolerances and products meet required quality & regulatory standards.
• Program Management:
  Support delivery of equipment and automation scope on time and within budget.
• Finance Team:
  Support Cap Ex tracking and reporting.

1. Process & Equipment Design and Development

• Support design and development of assembly, packaging, automation, inspection, and manufacturing equipment including mechanical, electrical, and control elements.
• Support preparation, maintenance, and execution of User Requirement Specifications (URS).
• Support evaluation of technical concepts considering risk, scalability, validation impact, cost, and lifecycle requirements.
• Participate in design reviews, machine safety reviews, risk assessments, and FMEA activities.
• Lead Proof of Concept (POC) evaluations and Design of Experiments (DOE).
• Verify relationships between Key Process Input Variables (KPIVs) and Key Process Output Variables (KPOVs).
• Develop center lining activities to optimize equipment performance.
• Identify opportunities to improve equipment operability, ergonomics, maintainability, reliability, and cost of ownership.
• Lead and support problem solving activities related to Equipment & Automated Systems.
• Troubleshoot equipment systems, materials, or process issues using scientific approaches.
• Lead and Support POC evaluation and DOE to establish baseline processes and metrics.

2. Supplier & Capital Project Support

• Support coordination with equipment suppliers and system integrators.
• Support RFQs, technical evaluations, and supplier capability reviews.
• Review supplier designs, specifications, and safety concepts under guidance.
• Participate in Factory Acceptance Tests (FAT) and Site Acceptance Tests (SAT).
• Support deviation tracking, corrective actions, and issue resolution.

3. Equipment Integration, Installation, Validation & Start-Up

• Support execution of equipment installation plans and site readiness activities.
• Execute and support qualification, process verification, and process validation activities.
• Support vertical start-up and production ramp-up activities.
• Minimize disruption to ongoing operations during equipment or automation integration.
• Troubleshoot equipment and automation issues using structured problem-solving tools.
• Execute process verification and production ramp-up activities for Equipment & Automated Systems.

4. Ramp-Up, Performance & Continuous Improvement

• Provide technical support during ramp-up to achieve OEE, yield, throughput, and reliability targets.
• Measure and analyze gaps between expected and actual performance.
• Lead continuous improvement and Lean Manufacturing initiatives.

5. Documentation, Training & Handover

• Support creation and handover of equipment documentation including specifications, drawings, FAT/SAT, validation, maintenance and control plans.
• Support preparation of operating instructions and troubleshooting documentation.
• Support training of site personnel on new equipment and processes.
• Support formal handover to Operations, Maintenance, Engineering, and Quality teams.

6. Compliance, Safety & Quality

• Ensure compliance with EHS, machine safety, ISO, FDA, GMP, and BD Quality System requirements.
• Support internal and external audits, inspections, and regulatory interactions.

Equipment Engineering Scope

• Execute process verification, process validation, and production ramp-up activities for Equipment & Automated Systems.

7. Performance Indicators (Accountability)

• Leading KPI:
  Number of Equipment design, Cost of production & OEE. Percentage of project completed on time, in scope and to budget.
• Integration lead time reduction and milestone adherence.
• Completion of validation and readiness activities.

Lagging KPI:
Equipment Reliability Overall Equipment Effectiveness Number of process failures experienced.

Lagging KPI:
Equipment OEE and reliability during ramp-up.

Equipment-related quality or safety incidents.

Experience/Education

Minimum Education:

• Bachelor's Degree in Mechanical Engineering, Controls…