Supplier Engineer II, Metals (1 of 2) - 2306136346W

　　Description

　　ABIOMED is redefining team-driven success while reshaping heart recovery. Here, new ideas are welcomed and encouraged, learning is constant, and our dynamic setting enables positive people to do profoundly important work.

　　If you have: the ability to build and grow strategic partnerships, a keen focus on consistency of methods and moving the company forward, and the desire to make a true impact on patient health, we want to hear from you. Discover your true potential as you work with Suppliers, Manufacturing and Design teams, develop professionally, and contribute to a company imagining the future of heart care.

　　This role 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 custom metal components

　　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

　　Partner with supplier’s engineering teams to develop inspection methods and validate through GR&R

　　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 DFM (Design for Manufacturing) improvements at the design phase

　　Provide input on second source selection and qualify processes at second source suppliers

　　Qualifications

　　Required:

　　Bachelors degree in mechanical engineering, manufacturing engineering or related

　　3 years experience in professional field

　　Knowledge of Swiss Screw machining capabilities, precision milling, reaming, drilling, grinding, EDM, laser cutting, electropolishing, tumble/abrasion deburring, laser welding

　　Demonstrated experience working at a manufacturer who designs, manufactures and/or assembles components with micron level tolerances and are made from high performance materials, including stainless steels, titanium, ceramics, kanthal

　　Demonstrated experience working on a manufacturing floor with hands on ownership of processes/equipment development/improvement, operator interactions, non-conformance management

　　Demonstrated experience developing process validation plans, including IQ/OQ/PQ protocols and reports

　　Demonstrated experience performing Gauge R&R studies

　　Demonstrated experience performing ranging studies/DOE to optimize processes

　　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

　　Knowledge of project management fundamentals, including schedule and stakeholder management

　　Working knowledge of Microsoft Office Suite

　　Knowledge of FDA 21CFR820/821 and ISO 13485 requirements

　　Willingness to travel up to 20% within the United States

　　Preferred:

　　Working knowledge of SAP

　　Green belt certified with proven classroom/project completion

　　Primary Location NA-US-4887-Danvers

　　Organization ABIOMED Inc.(6942)

　　Job Function Quality Engineering

　　Req ID: 2306136346W