Summary:Major contributor of the project team responsible for process deployment and new product introductions for internal and external transfer of production into Nypro facilities.
Apply Lean Manufacturing methodology to develop medical device manufacturing lines in accordance with throughput and quality targets.
Participates in Kaizen events and drives continuing improvements in line efficiency through application of learnings.
Define a manufacturing line layout (footprint and equipment strategy) that meets the required Takt Time and specifies Standard Work Instruction for all operations.
Performs cost benefit analysis of capital expenditures and make vs. buy scenarios for manufacturing equipment.
Assist with fixture development through specifying performance and user requirements based on manufacturing site requirements.
Specify and purchase manufacturing and test equipment.
Plan, execute and document engineering studies using DOE methodology and analyzes data regarding quality and throughput and implements initiatives to improve trends.
Perform root cause analysis and methodical problem resolution as related to process development.
Assist with documentation for Design Verification and Validation builds.
Setup the manufacturing line for Design Verification and Validation builds.
Conduct and execute Process FMEA.
Develop Device Master Record documentation.
Create the Master Validation Plan.
Write and execute validation protocols and reports.
Support Quality in development of a control plan for the established production line.
Line transfer to NPI site.
Knowledge of engineering design principles
Read and interpret product DWGs.
Ability to navigate SolidWorks is a plus.
Generate and release DMR documentation.
Lean Six Sigma Certification. Black Belt Certification preferred.
DOE planning, execution, analysis and documentation using Minitab.
Root cause analysis and resolution.
Understanding of medical design procedures with respect to design controls
Understanding of rapid prototyping methods, design for manufacturability, tolerance analysis methods
Expert knowledge of manufacturing processes common to the medical device industry, specifically those used in high-volume products.
Ability to select the appropriate manufacturing technology and strategy for a given product scenario.
Specification, protocol report requirements and the ability to author
Bachelors or equivalent
6+ years of experience
Or Masters and 4 - 6 years of experience