Job Summary
| Process Quality |
| • Develop measurement systems/capabilities, destructive tests, non-destructive tests for manufacturing processes. |
| • Develop control plans consistent with product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls, etc. |
| • Develop, interpret and implement appropriate process monitoring and control methods consistent with the level of process/product risk. |
| • Collect data and execute/conduct various analytical/statistical analysis and interpretations as part of process improvements and day-to-day support. |
| • Develop, interpret and implement standard and non-standard sampling plans |
| • Assess the effectiveness of measurement tools, destructive tests, non-destructive tests, measurement system analysis. |
| • Accountability and ownership for sampling plans of all types including the acceptability of risk given the product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls, etc. including assessing, applying and interpreting acceptance sampling standards for manufacturing data. |
| • Assess and interpret common versus special cause variation in manufacturing processing and determine the adequacy of current process limits. |
| • Technical training and experience using Statistics, Lean and Six Sigma Methodologies are required including Measurement System Analysis, SPC, DOEs, |
| • A thorough understanding of GMP/ISO regulations and validation regulations is preferred. Reliability, etc. |
| Hands on expereince is mandatory |
Key Responsibilities
1. Collaborate With Stakeholders To Gather And Refine Manufacturing Process Design Requirements, Ensuring Alignment With Project Goals And Customer Expectations.
2. Develop Prototypes And Proof-Of-Concept Implementations Using Tools Such As Cad Software And Simulation Technologies To Validate Design Decisions And Optimize Manufacturing Processes.
3. Mentor Junior Designers By Sharing Knowledge And Expertise Through Structured Training Sessions And Comprehensive Design Documentation, Fostering A Culture Of Continuous Improvement.
4. Collaborate With Cross-Functional Teams, Including Engineering And Production, To Ensure That Manufacturing Designs Are Integrated Seamlessly With Overall Project Objectives And Timelines.
5. Partner With Quality Assurance Teams To Establish And Uphold High-Quality Standards In Manufacturing Process Planning, Conducting Design Reviews And Validations To Maintain Excellence.
Skill Requirements
1. Strong Understanding Of Manufacturing Process Planning Principles And Methodologies.
2. Proficiency In PLM software Windchill
3. Familiarity With Prototype Development And Proof-Of-Concept Methodologies.
4. Good Communication And Collaboration Skills To Work Effectively With Cross-Functional Teams And Stakeholders.