Senior Process Engineer II

Integra LifeSciences•Plainsboro Township, NJ

About The Position

The Sr. Process Engineer is responsible to understand, optimize, and sustain manufacturing processes within a value stream leveraging lean and six sigma tools and methodologies to improve processing, layout, workflow, assets, assembly methods, and workforce usage to process efficiency. They are responsible for end-to-end process and product understanding and control and manage managing lifecycle sustaining engineering changes. They plan and execute of their duties in compliance with corporate policies, U.S. Food and Drug Administration regulations, Good Manufacturing Practices (GMP), ISO 9001, ISO 13485, EU MDR, the Canadian Medical Device Regulations (CMDR), and other applicable regulatory agencies.

Requirements

A Bachelor’s degree in engineering or equivalent with 5+ years of experience; Master’s degree with 3+ years of experience.
Experience with statistical process control tools required (SPC, Minitab, other software) required.
Lean Six Sigma experience required
Demonstrate excellent organizational and English communication skills (oral & written)
Sound interpersonal, and employee development skills
Project management and process improvement experience, PMP desired
Knowledge in enterprise resource planning, material resource planning, and MS Office skills

Responsibilities

Develop a cross-functional network with Environmental, Health, & Safety (EHS), product development, process technology, Centers of Excellence (CoE's), facilities, quality, regulatory, planning, procurement to address process challenges, rial changes, and well as lifecycle and sustaining changes.
Represent value stream teams in strategic site and enterprise projects on cross-functional teams addressing quality improvements, lifecycle management efforts, new product introductions, etc.
Initiate, develop and implement engineering studies, IQ/OQ/PQ/TMV validations, manufacturing process requirements, specifications, Engineering Change Requests/Orders (ECR/ECO), and Engineering Drawings for equipment and processes.
Leverage statistical process control (as necessary), analyze and trend existing process parameters, process inputs and outputs, improve manufacturing yields, reduce manufacturing scrap, and error proof manufacturing processes.
Perform timely technical investigations, non-conformance, Failure Mode Effects Analysis (FMEA), and Corrective and Preventive Action (CAPA).
Identify, financially justify, and lead projects to drive process, quality, reliability and cost improvements leveraging advanced technologies, lean six-sigma tools and methodologies.
Ensure value stream(s) BOMS, routers, and work instructions to align with process and ensure cost accuracy from product transfer through product lifecycle.
Complete process improvements actions to ensure performance metrics attain targeted performance Key Performance Indicators (KPI's).
Develop hands-on product/process/equipment training programs.
Lead cross-functional process and product project teams including product development, quality assurance, facilities, regulatory, and manufacturing.
Complete other job-related duties as assigned.