Abiomed is a pioneer and global leader in healthcare technology and innovation, with a mission ofRecovering Hearts & Saving Lives. With corporate headquarters in Danvers, Massachusetts, offices in Aachen & Berlin, Germany and Tokyo, Japan, Abiomed's 1,700 employees form one of the fastest growing medical device companies in the world. We attract and retain exceptional talent with our collaborative culture, passion for our work, and a strong commitment to employee professional development.
Patients First | Innovation | Winning Culture | Heart Recovery
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, GageR&Rstudies, 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; and
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 reuired, 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, QSRand ISOregulations
Demonstrated knowledge of the product development process in a medical device environment
10% international travel required.
Abiomed is an Equal Opportunity Employer committed to a diverse workforce. Abiomed will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, gender identity, national origin, ancestry, age, sexual orientation, gender identity, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.