EDI Engineer 3

Becton Dickinson Medical DevicesColumbus, OH
Onsite

About The Position

This position is responsible for supporting Automation and Equipment Design and Process Implementation across the MDS business. The role supports the integration and execution of manufacturing equipment and automation solutions at BD production sites, working in partnership with the sites to achieve seamless transition and rapid start-up. 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. 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: Support ensuring 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 CapEx tracking and reporting.

Requirements

  • Bachelor’s Degree in Mechanical Engineering, Controls Engineering or related field, or relevant equivalent experience.
  • 1 year of progressively responsible engineering and project management experience.
  • Good technical skills including project management, organization, planning, and capital budgets.
  • Ability to apply problem solving and data analysis methods.
  • Lean leadership experience who can assimilate data in a structured manner and present recommendations based on facts and data.
  • Good communication and presentation skills.
  • Ability to use a laptop/computer for extended periods of time (up to 8 hours)
  • Ability to sit for long periods of time (up to 8 hours) in virtual and/or on-site meetings
  • Ability to stand for long periods of time (up to 8 hours) when conducting FAT, SAT, on-site equipment/process troubleshooting, etc.
  • Ability to climb steps, squat, etc.
  • Ability to work independently in High Volume manufacturing floor
  • Follow Safety and Quality/GMP requirements for medical device manufacturing site (Safety shoes, safety glasses, hair net, beard net, face mask, hard hat, etc….as required per manufacturing site)

Nice To Haves

  • Desired experience in integrating equipment within complex manufacturing sites with a strong focus on validation and vertical start up.
  • Experience in SolidWorks or other 3d modeling software is desired
  • Desired knowledge in project and capital management.

Responsibilities

  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • Support ensuring compliance with EHS, machine safety, ISO, FDA, GMP, and BD Quality System requirements.
  • Equipment Engineering Scope Support execution of process verification, process validation, and production ramp-up activities for Equipment & Automated Systems.

Benefits

  • Competitive pay
  • Access a portion of your pay before pay day with DailyPay
  • Healthcare coverage: No paycheck contributions for eligible associates under a certain salary threshold enrolled in the HSA Basic Medical Plan option, no matter how many dependents you cover. Preventive care covered at 100%.
  • Dental and vision insurance at group rates.
  • Paid parental leave up to 6 weeks
  • Adoption assistance plan
  • 401(k) plan with 75 cents on the dollar matched by BD up to 6% of compensation
  • Company paid basic life and AD&D insurance
  • Tuition reimbursement
  • Discounted home, auto and pet insurance
  • Paid holidays and vacation (pro-rated the first year based on actual start date)
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