Senior Supplier Engineer

Sr. Supplier Engineer – Supply Chain Engineering

At Johnson & Johnson, we believe health is everything. Our cardiology team focuses on leading solutions for heart recovery, electrophysiology, and stroke. The Sr. Supplier Engineer will serve as ABIOMED’s primary technical contact with all U.S. based suppliers, lead all supplier initiatives, and establish “Quality at the Source” programs with key partners.

• Act as the primary technical point of contact with suppliers who provide electronic assemblies, electrical components, PCBAs or consoles/box builds.
• Lead frequently recurring meetings with suppliers to manage engineering projects, including process validations, failure analysis, component obsolescence mitigations and manufacturing capacity increases.
• Partner with supplier’s engineering teams to analyze manufacturing processes and use data to develop and execute yield improvement project plans.
• Partner with supplier’s engineering teams to perform process constraints analysis and develop capacity increase plans based on Abiomed delivery forecasting.
• Assess risk through FMEAs and develop process validation plans (MVP, IQ/OQ/PQ) to be executed at supplier.
• Partner with internal design teams to assess product lifecycle design changes and develop and execute qualification test plans.
• Act as a technical partner with internal incoming inspection teams to assess defects and manage non-conformance investigations.
• Use project management tools to set milestone targets with suppliers and track and report out on deliverables.
• Support product development projects as a liaison responsible for supplier interactions and deliverables.
• Influence development team by representing capabilities of the supplier and push for DFx (Design for Manufacturing and Test) improvements at the design phase.
• Provide input on second source selection and qualify processes at second source suppliers.

• Bachelors degree required (Masters degree preferred) in electrical engineering, manufacturing engineering or related fields.
• 5+ years experience in a professional field, preferably at a manufacturer who designs, manufactures and/or assembles electrical components, PCBAs or consoles/box builds, plastic/injection molded parts.
• Demonstrated experience in printed circuit board manufacturing, SMT process, electrical component and assembly design theory (including PCB, batteries, cables/connectors, displays, and console/box design and manufacturing).
• Demonstrated experience designing, improving or supporting manufacturing of injection molded and/or extruded plastic components.
• Knowledge of the process flow for ordering, receiving and using custom direct materials; including generating incoming inspection plans, participating in MRB investigations, non-conformance generation and disposition, and management of product through ERP systems (SAP preferred).
• Demonstrated experience developing process validation plans, including IQ/OQ/PQ protocols/reports required.
• Experience designing and executing Gauge R&R studies preferred.
• Demonstrated experience with root cause investigation, including the ability to validate root cause by turning off and on the failure.
• Knowledge of statistical process control, including run charts, IM‑R charts, setting control limits and generally keeping a process in a state of control.
• Lean Six Sigma Green Belt or Black Belt preferred.
• Basic metrology skills, including experience with calipers, gauge pins, vision system/optical comparator.
• Working knowledge of project management fundamentals, including schedule and stakeholder management, conflict resolution and identifying critical path.
• Working knowledge of Microsoft Office Suite.
• Knowledge of FDA 21
  
  CFR
  820/821 and ISO 13485 requirements.
• Willingness to travel up to 20% within as well as outside of the United States.

• Agile Decision Making
• Coaching
• Corrective and Preventive Action (CAPA)
• Critical Thinking
• Emerging Technologies
• Issue Escalation
• Lean Supply Chain Management
• Problem Solving
• Process Control
• Process Engineering
• Product Costing
• Product Improvements
• Science, Technology, Engineering, and Math (STEM) Application
• Situational…