Develop and implement manufacturing business improvement projects and processes for disposable medical devices.Support teams to make improvements to existing devices and manufacturing processes.Lead less complex projects independently with minimal supervision.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.

Perform Six Sigma (Problem Solving and Process Improvement) and Lean tools to develop project opportunities to gain rates of improvement from manufacturing lines.Utilize Design of Experiments to optimize processes. Create documentation to support new and improved manufacturing processes. Write and perform process validations (IQ, OQ, PQ, PPQ) and validate methods for inspection for verification and process controls. Interface directly with assemblers, production supervisors, leads, engineers and management daily. Coordinates with the suppliers and external resources needed in developing and implementing new process/product plans.

Work as part of a development team in developing and implementing new devices.

Key Responsibilities:
1. Assesses process capabilities, prioritizes process improvement opportunities, and innovates and implements process improvements on commercial products.
2. Applies technical knowledge to innovate, design, and develop processes, procedures, tooling and/or automation.
3. Executes the functional deliverables associated with the the CAPA, VIP, Strategic Initiative, and Quality Systems.
4. Plans, organizes, and conducts all aspects of technical reviews.
5. Ensures proper documentation is completed to meet quality systems requirements. (e.g., BOM’s, Routers, FMEA’s, etc.)
6. Writes and reviews validation protocols and reports applicable to new processes.
7. Oversees development builds associated with the project using special work requests.
8. Develops and maintains qualified production lines.
9. Provides Design for Manufacturability (DFM) input to the e