EDI Staff Engineer

Job description

We are the people who give possibilities purpose 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 MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities. Job Description 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 CapEx tracking and reporting. RESPONSIBILITIES 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 Engineering or related field, or relevant equivalent experience. Minimum Experience: 3 years of progressively responsible engineering and project management experience. Extensive 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 Excellent technical skills including project management, organization, planning, and capital budgets. Demonstrated ability to apply problem solving and data analysis methods. Proven lean leadership experience who can assimilate data in a structured manner and present recommendations based on facts and data. Proven leadership in project and capital management. Exceptional communication and presentation skills. Physical requirement: 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) MAIN CONTACTS TO DO THE JOB: Internal Reasons GIE other Teams Manufacturing teams BU functions: Quality, SC. External Reasons Vendors, Customers, Consultants, procurement, Quality WW R&D project teams Machine vendors At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting. For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law. BD is committed to providing a robust set of value-based programs and resources that are best-in-class, market-competitive and affordable for all associates and their families. Competitive pay Access a portion of your pay before pay day with DailyPay Healthcare coverage: No paycheck contributions for