Report this Job
Role : Manufacturing Engineer
Location: Warsaw, IN
Technical/Functional Skills
Medical devices technical transfer experience
Experience supporting medical device manufacturing
Specific experience with process characterization, equipment IQ/OQ, process OQ, and PQ
NCR/NCE creation, review, and disposition
Specific experience with Test method Validation and Gage R&R
Experience with root cause analysis and problem-solving for both technical and process issues
Working knowledge of design control and cGMP requirements for medical device manufacturing per FDA QSR and ISO13485-2003Ability to lead and prioritize multiple medium-complexity project assignments and complete work in a timely manner
Good problem-solving skills through the use of 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
Demonstrates good written and verbal communication skills
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, process development, CNC programming terminology, and tooling design concepts
Microsoft Office Suite and Project
Roles & Responsibilities
Medical devices technical transfer
Supporting medical device manufacturing
Process characterization, equipment IQ/OQ, process OQ, and PQ
Test method Validation, Gage R&R
Creating, maintaining, and improving controlled technical documents such as prints, procedures, bills of materials, and routers.
Supporting a wide variety of processing applications such as machining, finishing, forging, casting, cleaning, heat treating, bonding, molding, etc.
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
Execute equipment qualification or process validation project(s)
Sysmind LLC
