What are the responsibilities and job description for the Manufacturing Engineer Warsaw - IN - Indiana position at Sierra Business Solution LLC?
Manufacturing Engineer
(Prior Zimmer Biomet experience is preferred)
TechnicalFunctional Skills
Experience supporting medical device manufacturing
Specific experience with process characterization, equipment IQOQ, process OQ, and PQ
Experience with root cause analysis and problem-solving for both technical and process issues
Good problem-solving skills using quality and statistical tools
BOM & Router creation and update
Ability to read and understand engineering drawings
Knowledge of basic quality tools, risk analysis (PFMEA), statistics (SPC), Critical-to Quality (CTQ) Analysis
Knowledge of Quality System requirements, ISO and FDA requirements
Ability to effectively work within a cross-functional team to complete critical project tasks
Experienced with control procedures, such as the Change Management System, Nonconformance Reports, Engineering Specifications, Corrective and Preventive Action (CAPA), and Work Instructions & Proficient with Statistical Process Control concepts
Microsoft Office Suite and Project
Leads continuous improvement initiatives, manages change controls, troubleshoots cleaning problems, and ensures proper documentation and training.
Creating, maintaining, and improving controlled technical documents such as prints, procedures, bills of materials, and routers.
Conducting feasibility study to estimate a product cost and analyze capital equipment, capacity, and capability requirements
Establishing and improving process methods that meet performance and quality requirements
Developing and executing project plans and schedules for work activities
Communicate (written and verbal) direction and project plans with appropriate personnel from other departments.
Evaluating multiple options to select the most appropriate processes and machining methods
Generic Managerial Skills Not Mandatory
Salary : $36