As the Process Improvement and Development Engineer you will own the technical aspects of the processes you are assigned. Design, develop, improve and validate manufacturing processes, tooling, and fixtures in order to meet daily and long range production schedules. Control manufacturing processes while reducing defects, enhancing productivity, and product quality. In addition the Process Improvement and Development Engineer is expected to mentor team members. We will consider either Senior Engineer or Engineer for this role.
Principle Duties and Responsibilities:
Use Lean and Six Sigma tools to analyze process trend data or communicate issues based upon data driven approach. Identify opportunities for process and yield improvement projects. Create and monitor SPC charts and develop action plans when necessary.
Analyze data trends; Obtain statistical data, analyze data, and recommend courses of action based upon quantitative results.
Qualify and optimize processes and tooling via IQ/OQ/PQ, Gage R&R Studies, Process Capability Studies and Designs of Experiments.
Mentor peers on areas of engineering expertise; Be an agent of change, constantly moving the team towards improvements in technical skills and system knowledge.
Anticipate potential issues before they arise by relying on prior experience and gaining new industry knowledge.
Support global projects, production floor support and production transfer efforts through recurring meeting coordination/attendance and, if needed, international travel between facilities, ensuring corporate objectives are met in a timely manner.
Support and enforce company goals and objectives, policies and procedures, Good Manufacturing Practices, Good Documentation Practices, FDA QSR and ISO regulations.
Develop and maintain process documentation including assembly procedures, test procedures, routers, travelers, BOMs, process flows, and process FMEAs.
Identify and execute process validations including generation of plans, protocols and reports.
Plan and schedule projects, estimating required timing, resources and budgets which are consistent with corporate objectives.
Regularly report on project status, schedule progress and key project metrics through scorecard presentations, action items and meeting minutes, and manufacturing readiness reviews with program and operations management.
Oversee outside supplier activity as appropriate, ensuring all technical issues are resolved in order to meet production demand.
Participate in the investigation of failures and formulation and implementation of action plans for all internal corrective actions, audit findings. Address WIP and Incoming MRB in a timely manner.
Maintain accurate documentation of concepts, designs, and processes while maintaining current knowledge of medical, technical, and biomedical developments as related to Abiomed products.
Work with product development staff to ensure that products under development are designed for manufacture, test, and inspection as appropriate.
Skills/Requirements
BS in engineering or statistics required, MBA or MS desired.
3-5 years of related work experience desired. Medical device experience strongly preferred.
Exceptional skills analyzing statistical parameters leading to quantifiable solutions. Minitab (or equivalent) skills a must.
Knowledge of lean, six sigma, kaizen, and continuous improvement initiatives. Black Belt strongly preferred.
Intimate knowledge of FDA, QSR and ISO regulations required.
Ability to Communicate ideas and information clearly, effectively, and frequently (oral and written) within the internal project team
Ability to exercise judgment in selecting, methods, techniques, and evaluation criteria for obtaining results.
Execute tasks in a timely manner without direct supervision.
Must be proficient in Microsoft Office Suite. Working knowledge of SAP desired.
