Staff Process Engineer

Integra LifeSciences•Plainsboro Township, NJ

1d•Hybrid

About The Position

Changing lives. Building Careers. Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what’s possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care. The Staff 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 develop end-to-end process and product understanding and control and address lifecycle management and sustaining engineering changes. They 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. These positions operate with increasing independence, technical depth, and leadership responsibility commensurate with level assignment. CORE RESPONSIBILITIES (ALL LEVELS) Work cross-functionally with EHS, product development, process technology, Centers of Excellence (CoE's), facilities, quality, regulatory, planning, procurement to address process challenges, material 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. Execute engineering studies, IQ/OQ/PQ/TMV validations, manufacturing process requirements, specifications, Engineering Change Requests/Orders (ECR/ECO), and Engineering Drawings for equipment and processes. Conduct statistical process control (as necessary) analysis and trending of 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). Complete projects to drive process, quality, reliability and cost improvements leveraging advanced technologies, lean six-sigma tools and methodologies. Conduct time studies, process evaluations, and technical evaluations to align Bills of Materials, work instructions, and routers with process to ensure cost accuracy from product transfer through product lifecycle. Monitor performance metrics for value stream(s) and develop improvement actions necessary to attain targeted performance Key Performance Indicators (KPI's). Develop hands-on product/process/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. STAFF PROCESS ENGINEER Provide strategic process engineering leadership for manufacturing operations and quality systems. Own and resolve high-risk, complex process issues with significant business or regulatory impact. Lead site-level or enterprise-level process improvement and compliance initiatives. Define best practices, standards, and methodologies for process engineering activities. Respond and resolve immediate escalations from manufacturing floor and escalate to leadership / appropriate parties as needed. Mentor Process Engineers and influence cross-functional teams without direct authority.

Requirements

Bachelor’s degree in Engineering or Science
8+ years Process / Manufacturing Engineering experience in regulated manufacturing.
Advanced certifications strongly preferred.

Responsibilities

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.
Develop end-to-end process and product understanding and control and address lifecycle management and sustaining engineering changes.
Execute engineering studies, IQ/OQ/PQ/TMV validations, manufacturing process requirements, specifications, Engineering Change Requests/Orders (ECR/ECO), and Engineering Drawings for equipment and processes.
Conduct statistical process control (as necessary) analysis and trending of 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).
Complete projects to drive process, quality, reliability and cost improvements leveraging advanced technologies, lean six-sigma tools and methodologies.
Conduct time studies, process evaluations, and technical evaluations to align Bills of Materials, work instructions, and routers with process to ensure cost accuracy from product transfer through product lifecycle.
Monitor performance metrics for value stream(s) and develop improvement actions necessary to attain targeted performance Key Performance Indicators (KPI's).
Develop hands-on product/process/equipment training programs.
Participate in cross-functional process and product project teams including product development, quality assurance, facilities, regulatory, and manufacturing.
Provide strategic process engineering leadership for manufacturing operations and quality systems.
Own and resolve high-risk, complex process issues with significant business or regulatory impact.
Lead site-level or enterprise-level process improvement and compliance initiatives.
Define best practices, standards, and methodologies for process engineering activities.
Respond and resolve immediate escalations from manufacturing floor and escalate to leadership / appropriate parties as needed.
Mentor Process Engineers and influence cross-functional teams without direct authority.