Johnson & Johnson MedTech · 1 day ago
Senior Supplier Engineer
Johnson & Johnson MedTech is focused on healthcare innovation to build a world where complex diseases are treated and cured. The Senior Supplier Engineer will serve as the primary technical contact with US-based suppliers, lead product development initiatives, and establish quality programs with key partners to enhance patient care in cardiovascular treatments.
Hospital & Health Care
Responsibilities
Act as the primary technical point of contact with suppliers who provide electronic components and custom assemblies (PCBAs, consoles, cables, batteries, housings, etc.) as well as custom injection molded or extrusion components and/or multi-component sub-assemblies
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 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
Qualification
Required
Bachelors degree required in electrical engineering, mechanical engineering, manufacturing engineering or related fields
5+ years of experience in professional field, preferably at a manufacturer who designs, manufactures and/or assembles electrical system 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 required
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
Willingness to travel up to 20% both within US and International
Preferred
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
Benefits
Medical
Dental
Vision
Life insurance
Short- and long-term disability
Business accident insurance
Group legal insurance
Consolidated retirement plan (pension)
Savings plan (401k)
Long-term incentive program
Vacation – up to 120 hours per calendar year.
Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year.
Holiday pay, including Floating Holidays – up to 13 days per calendar year.
Work, Personal and Family Time - up to 40 hours per calendar year.
Company
Johnson & Johnson MedTech
At Johnson & Johnson MedTech, we are working to solve the world’s most pressing healthcare challenges through innovations at the intersection of biology and technology.