EDI Engineer

Job Title

This position is responsible for supporting Automation and Equipment Design and Process Implementation across the MDS business.

The Engineer 1 role applies foundational engineering principles to support equipment design, supplier execution, installation, validation, and production ramp-up activities under guidance of senior engineers. This role builds foundational technical knowledge and execution experience while contributing to business, quality, safety, and regulatory objectives.

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.
• Support Proof of Concept (POC) evaluations and Design of Experiments (DOE).
• Support verification of relationships between Key Process Input Variables (KPIVs) and Key Process Output Variables (KPOVs).
• Support center lining activities to optimize equipment performance.
• Identify opportunities to improve equipment operability, ergonomics, maintainability, reliability, and cost of ownership.
• Support problem solving activities related to Equipment & Automated Systems.
• Support troubleshooting of equipment systems, materials, or process issues using scientific approaches.
• Support POC evaluation and DOE to establish baseline processes and metrics.
• Support verification of relationships between Equipment KPIVs and KPOVs.

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.
• Support execution of 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.
• Support troubleshooting of equipment and automation issues using structured problem-solving tools.
• Support execution of 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.
• Help the project leader to Measure and analyze gaps between expected and actual performance.
• Support 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

• Support ensuring compliance with EHS, machine safety, ISO, FDA, GMP, and BD Quality System requirements.

Minimum Education:

• Bachelor's Degree in Mechanical Engineering, Controls Engineering or related field, or relevant equivalent experience.

Minimum Experience:

• 1 year of progressively responsible engineering and project management experience.
• Desired experience in integrating equipment within complex manufacturing sites with a strong focus on validation and vertical start up.
• Experience in Solid Works or other 3d modeling software is desired
• Good technical skills including project management, organization, planning, and capital budgets.
• Ability to apply problem solving and…