GIE - EDE Staff Engineer

Job Title

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 Med Tech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.

Responsibilities:

• Product Design / R&D Teams:
  Ensure products are designed to enable efficient, scalable, and compliant manufacturing processes meeting cost, quality, and regulatory objectives.
• Manufacturing & Operations Teams:
  Ensure integrated equipment and processes are operable, reliable, maintainable, and capable of meeting production targets from handover through steady-state operations.
• Quality & Regulatory Teams:
  Ensure compliance with validation strategies, GMP, ISO, FDA, and internal quality system requirements.
• Maintenance & Engineering Teams:
  Ensure long-term equipment reliability, center lining strategies, spare parts management, and maintenance readiness.
• Program & Project Management:
  Ensure alignment on scope, cost, schedule, risk, and delivery milestones.
• Procurement, Suppliers, and Vendors:
  Drive supplier technical alignment, capability development, and delivery performance.
• Finance:
  Support Cap Ex planning, forecasting, and reporting.
• EHS Teams:
  Ensure machine safety, ergonomics, environmental compliance, and risk mitigation.

1. Process & Equipment Strategy, Design and Development

• Provide technical ownership and strategic direction for assembly, packaging, automation, inspection, molding, press, and manufacturing equipment.
• Translate business, product, quality, and capacity requirements into robust end-to-end equipment and automation strategies.
• Define, create, review, and approve User Requirement Specifications (URS) ensuring clear translation to supplier designs and site needs.
• Lead the development and evaluation of multiple technical concepts, architectures, and solutions considering risk, scalability, standardization, lifecycle cost, and validation impact.
• Develop innovative mechanical and automation concepts aligned with BD standards, industry best practices, and emerging technologies.
• Review and approve mechanical, electrical, and controls architectures, layouts, 3D models, 2D drawings, and system interfaces.
• Provide expert oversight of engineering analyses and simulations (stress, strain, thermal, airflow, cycle time) to validate and optimize designs.
• Lead and approve design reviews, machine safety reviews, risk assessments, and FMEA activities.
• Support and lead Proof of Concept (POC) activities and Design of Experiments (DOE) to define process windows and establish baseline performance.
• Verify and approve relationships between KPIVs and KPOVs and ensure process capability is demonstrated.
• Optimize equipment and process designs to improve performance, reliability, ergonomics, changeover time, maintainability, manufacturability, and total cost of ownership.
• Provide authoritative technical and cost input to capital justification (CB-2) including risk, validation effort, and sustainability of performance.

2. Supplier, Vendor & Capital Program Leadership

• Act as technical lead for supplier and system integrator engagement on large or complex capital programs.
• Lead and approve vendor selection, RFQs, and technical evaluations in partnership with Procurement.
• Define and control supplier technical scope, interfaces, cost, lead time, risks, and performance expectations.
• Review and approve supplier designs, specifications, safety concepts, automation architecture, and documentation.
• Lead, witness, and approve Factory Acceptance Tests (FAT) including acceptance criteria, deviation management, and corrective actions.
• Oversee supplier issue resolution, design changes, and continuous improvement actions.
• Support contract execution, change management, and claims resolution with Procurement and Legal.
• Establish and maintain strong long-term technical relationships with strategic equipment suppliers.

3. Equipment Integration, Validation &…