Abiomed, part of Johnson & Johnson Medtech, is currently recruiting for a Sr Supplier Process Engineer I (Staff level) to be based 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.jnj.com/.
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.
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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
• 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
• 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
• Bachelors degree in mechanical engineering, manufacturing engineering or related
• 6+ 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, and/or nitinol
• Knowledge of the process flow for ordering, receiving and using custom direct materials; this includes generating incoming inspection plans, participating in MRB investigations, non-conformance generation and disposition, and management of product through ERP systems (SAP preferred)
• 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
• Working knowledge of SAP a plus
• Lean Six Sigma Black Belt Certified with proven classroom/project completion a plus
• Willingness to travel up to 20% within the United States
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.