Process Engineer II

Integra LifeSciences•Mansfield, MA

10d•$71,300 - $97,750

About The Position

The Process Engineer II understands, optimizes, and sustains manufacturing processes within a value stream. The role applies lean and Six Sigma tools and methodologies to improve processing, layout, workflow, assets, assembly methods, and workforce usage to increase process efficiency. The engineer develops end-to-end process and product understanding and manages process control, lifecycle management, and sustaining engineering changes. The position carries out its duties in compliance with corporate policies and applicable regulations and standards, including U.S. Food and Drug Administration regulations, Good Manufacturing Practices (GMP), ISO 9001, ISO 13485, EU MDR, and Canadian Medical Device Regulations (CMDR).

Requirements

Bachelor’s degree in Chemical Engineering, Mechanical Engineering, or a related engineering discipline.
Minimum of 3 years of industry experience in engineering.
Computer proficiency.

Nice To Haves

Medical device industry experience.
Lean Six Sigma experience.
Cleanroom manufacturing experience.

Responsibilities

Work cross-functionally with EHS, product development, process technology, Centers of Excellence, facilities, quality, regulatory, planning, and procurement to address process challenges, material changes, lifecycle changes, and sustaining changes.
Represent value stream teams on strategic site and enterprise projects addressing quality improvements, lifecycle management, and new product introductions.
Execute engineering studies, IQ/OQ/PQ/TMV validations, manufacturing process requirements, specifications, Engineering Change Requests and Orders (ECR/ECO), and engineering drawings for equipment and processes.
Conduct statistical process control analysis and trending of existing process parameters and process inputs and outputs as needed; improve manufacturing yields, reduce scrap, and error-proof manufacturing processes.
Perform timely technical investigations, non-conformance investigations, Failure Mode and Effects Analysis (FMEA), and Corrective and Preventive Action (CAPA).
Complete projects to improve process, quality, reliability, and cost using advanced technologies and lean Six Sigma tools and methodologies.
Conduct time studies, process evaluations, and technical evaluations to align Bills of Materials, work instructions, and routers with processes and ensure cost accuracy from product transfer through product lifecycle.
Monitor value stream performance metrics and develop improvement actions to attain targeted Key Performance Indicators (KPIs).
Develop hands-on product, process, and equipment training programs.
Participate in cross-functional process and product project teams, including product development, quality assurance, facilities, regulatory, and manufacturing.
Complete other job-related duties as assigned.