GIE - EDE Staff Engineer

Job Description Summary

GIE EDE Staff Engineer responsible for Assembly Design and Process Implementation across the Medical Segment. This role ensures component design, supply, cost, and other engineering attributes align with business expectations. The engineer mentors peers, manages equipment development, and builds strong technical relationships with external vendors.

• Medical segment manufacturing process technology across all manufacturing sites & all products.
• Build competitive advantage for the Medical segment business by leveraging manufacturing process technology.
• Lead projects focused on developing equipment for the Medical segment, including URS creation, equipment design, FAT execution, support SAT completion, vendor selection, and purchase orders.
• Manage one or several projects to achieve successful outcomes.

• Design assembly and packaging equipment, ensuring user requirement specifications (URS) meet manufacturing requirements.
• Provide cost input for equipment, engineering, and materials into CB-2.
• Manage integration of new equipment through SAT completion and support installation/startup.
• Implement process design on new equipment and verify product designs are met.
• Lead suppliers and external design teams, managing cost, lead time, and scope.
• Collaborate with procurement for vendor selection.
• Participate in process optimizations and continuous improvements on automation projects.
• Capture process performance from sites and existing assembly lines.
• Develop innovative concepts for mechanical systems and equipment.
• Create and maintain 3D models/2D drawings of mechanical components and assemblies.
• Create and maintain design documentation, including URS, assembly instructions, and bills of process.
• Optimize equipment designs to minimize production costs and changeover time.
• Conduct design reviews, risk assessments, and FMEA to ensure reliability and safety.
• Collaborate with manufacturing teams to test prototypes and iterate designs.
• Perform engineering analyses and simulations (stress, strain, thermal, fluid dynamics).
• Support operations during production crises.
• Comply with local, state, federal, and BD safety regulations and quality policies.
• Perform additional duties as assigned.

• Cost of production & OEE; percentage of projects completed on time, in scope, and to budget.

• Reliability:
  Overall Equipment Effectiveness; number of process failures experienced.

• Minimum Education:
  
  Bachelor’s Degree in Mechanical Engineering, Electrical Engineering, or related field.
• Minimum Experience:
  
  5+ years in assembly equipment design and procurement.
• Tooling design experience for assembly processes is desired.
• Proficiency in Solid Works is desired.
• Excellent technical skills including project management, organization, planning, and capital budgets.
• Demonstrated problem solving and data analysis methods.
• Experience with GMP, ISO standards, and Lean Manufacturing concepts is desired.
• Experience in an FDA-regulated quality environment is desired.
• Willingness and ability to travel domestically and internationally up to 40%.
• Experience leading projects end-to-end.
• Strong communication skills.
• Risk analysis / FMEA experience.
• Statistical analysis / SPC system experience.
• Ability to manage multiple conflicting priorities.
• Ability to develop and maintain tool qualification schedules.

• Use a laptop/computer for extended periods (up to 8 hours).
• Sit for long periods (up to 8 hours) in virtual or on-site meetings.
• Stand for long periods (up to 8 hours) during FAT, SAT, and on‑site troubleshooting.
• Climb steps, squat, etc.
• Work independently on high‑volume manufacturing floor.
• Follow Safety and Quality/GMP requirements (e.g., safety shoes, glasses, hair net, face mask).

• Internal: GIE other Teams, Plant Leadership Team and manufacturing teams, BU functions (Quality, Supply Chain, Customer‑facing, R&D teams).
• External:
  Vendors, Customers, Consultants, procurement, Quality, WW R&D project teams, machine vendors.

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For certain roles at BD, employment is contingent upon receipt of sufficient proof that you are fully vaccinated against COVID‑19.…