Sr Production Engineer
Abiomed has an immediate opportunity for Sr. Production Engineer I. This individual will design, develop, improve, and validate our company’s manufacturing processes, tooling, and fixtures in order to meet daily and long-range production schedules.
Principal Duties and Responsibilities:
Control manufacturing processes while reducing defects and enhancing productivity and product quality.
Use Lean and Six Sigma tools to analyze process trend data and communicate issues using a data-driven approach.
Identify opportunities for process and yield improvement projects.
Anticipate potential issues before they arise by relying on prior experience and new industry knowledge;
Qualify and optimize processes and tooling via IQ/OQ/PQ, Gage R&R studies, process capability studies, and designs of experiments.
Work collaboratively with peers on areas of engineering expertise while acting as an agent of change focused on improving technical skills and system knowledge.
Develop and maintain process documentation, including assembly procedures, test procedures, routers, travelers, BOMS, process flows, and process FMEAs.
Participate in the investigation of non-conforming product and implement action plans for all internal corrective actions and audit findings.
Develop data systems for defect tracking and operator analysis, for process improvements resulting in yield improvement.
Conduct root cause investigations that include product teardowns, X-ray or CT-scan analysis using advanced vision systems.
Apply working knowledge of dispensing processes with adhesives that are critical to component assembly.
Apply understanding of general properties of adhesives, such as, loctite, epo-tek, etc. which are critical to dispensability of the mater.
Bachelor’s degree in Mechanical Engineering, Industrial Engineering, or a closely related field required, advanced degree prefered.
5+ years of expereince required.
Demonstrated leadership in a process or manufacturing engineering capacity.
Demonstrated knowledge of Lean, Six Sigma, or continuous improvement initiatives.
Demonstrated knowledge of Minitab (or equivalent) skills.
Demonstrated ability with analyzing statistical parameters leading to quantifiable solutions.
Demonstrated knowledge of FDA, QSR and ISO regulations.
Demonstrated knowledge of the product development process in a medical device environment.
10% international travel required.
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