Senior Supplier Engineer

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

This role is for a Senior Supplier Engineer in the healthcare industry, focusing on electronic components and assemblies. The engineer will be the primary technical contact with US-based suppliers, leading initiatives for product development, second-sourcing, and establishing quality programs. Responsibilities include managing engineering projects, analyzing manufacturing processes, developing yield improvement plans, assessing risks with FMEAs, and creating process validation plans (IQ/OQ/PQ). The role also involves collaborating with internal design and inspection teams, supporting product development projects, and influencing design for manufacturing and test (DFM) improvements. Experience with FDA regulations (21CFR820/821) and ISO 13485 is required.

What you'd actually do

  1. Act as the primary technical point of contact with suppliers who provide electronic assemblies, electrical components, PCBAs or consoles/box builds
  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 electrical engineering, manufacturing engineering or related fields
  • 5+ 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
  • ISO 13485