SR ENG PROCESS ENGINEERING- ELECTRONICS

Abiomed, a member of the Johnson & Johnson Family of Companies, is currently recruiting for a Senior Supplier Engineer, to be in Danvers, MA.
At Johnson & Johnson, we believe health is everything.
Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal.
Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.
Learn more at https://www.
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I Am Abiomed | I Am Heart Recovery | Patients First! The Senior Supplier Engineer serves as ABIOMED’s primary technical contact with all US based suppliers, leads all product development team’s supplier initiatives, second source critical suppliers, and establishes “Quality at the Source” programs with key partners.
This role is a key technical resource for the company’s continued growth and is a great opportunity for someone to make a difference at one of the fastest-growing medical technology companies, focused on recovering hearts and saving lives.
Principal Duties and Responsibilities.
Act as the primary technical point of contact with suppliers who provide electronic components and custom assemblies (PCBAs, consoles, cables, batteries, housings, etc.) 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 Qualifications Bachelor’s degree required (master’s degree preferred) in electrical 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.
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).
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 21CFR and ISO requirements.
Willingness to travel up to 20% within the United States.
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