Process Engineer II

BASIC FUNCTION

Work with the product development team to translate prototypes into production ready, robust manufacturing processes for new products. Lead the development of processes and scale-ups into commercialization. Responsible for identifying and process ranging of critical process inputs and the execution of IQ, OQ and PQ. Support customer and company value through process and design for manufacturability.

PRINCIPLE DUTIES AND RESPONSIBILITIES

Perform process development and scale up activities in support of new product development projects using the DMAIC and DFM methodology or equivalent.
Using 6 Sigma tools, study, define, identify critical process inputs to understand their impact on the
manufacturing process outputs. Identify and minimize output variation.
Leads scale-up to test for manufacturing and quality issues
During development phase, investigate product quality issues through root cause analysis and implementation of corrective actions
Develop inspection methods and tooling and challenge thru MSA activity
Execute various project activities in support of a defined Stage Gate process. Presents metrics and objective evidence to upper management to support product maturation through the Stage Gate development life cycle.
Maintain proper documentation of technical and experimental activities within ISO 13845:2016. Maintain device history records within ISO 13485:2016.
Development of manufacturing documentation
Author and execute IQ/OQ/PQ’s and validation plans overseeing the training, builds and testing thru report writing and approval. Lead cross functional team to develop PFMEA’s to identify and mitigate risk. Lead team to develop control plans and understand the impact of validation activities and outcomes on process controls.
Transitions new and revised processes into manufacturing and performs initial training. Provides continued support for training, as needed, to ensure that operator proficiency is maintained.
Assesses and tracks yield labor and material to identify variances and defects. Summarizes and compares performance to projected standards and cost models to ensure robust, profitable processes are transferred to MFG.
Maintains compliance to the Pelham Plastics Quality Management System procedures. Adheres to the company's policies and procedures.

Performs all other duties as required or assigned.