Sr Eng Supplier Engineering

Johnson & Johnson Johnson & Johnson · Pharma · Danvers, MA +1

This role is for a Sr. Engineer in Supplier Engineering within the medical technology sector (ABIOMED). The primary focus is on managing technical aspects of supplier relationships for components and sub-assemblies, leading product development initiatives with suppliers, ensuring quality at the source, and driving process improvements and validations. It involves collaboration with internal design and inspection teams, risk assessment (FMEAs), and ensuring compliance with medical device regulations (FDA, ISO 13485).

What you'd actually do

  1. Act as the primary technical point of contact with suppliers who provide aessmbly custom injection molded or extrusion components and/or multi-component sub-assemblies and Finished goods.
  2. Lead frequently recurring meetings with suppliers to manage engineering projects, including process validations, failure analysis, component obsolescence mitigations and manufacturing capacity increases
  3. Partner with supplier’s engineering teams to analyze manufacturing processes and use data to develop and execute yield improvement project plans
  4. Partner with supplier’s engineering teams to perform process constraints analysis and develop capacity increase plans based on Abiomed delivery forecasting
  5. Assess risk through FMEAs and develop process validation plans (MVP, IQ/OQ/PQ) to be executed at supplier

Skills

Required

  • Bachelors degree in plastic engineering, manufacturing engineering or related fields
  • 3+ years experience in 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 plastics 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
  • 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.
  • 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 21CFR820/821 and ISO 13485 requirements

Nice to have

  • masters degree preferred
  • Experience designing and executing Gauge R&R studies preferred
  • Lean Six Sigma Green Belt or Black belt preferred
  • Working knowledge of SAP a plus

What the JD emphasized

  • FDA 21CFR820/821 and ISO 13485 requirements