Process Engineer II - Lean GMP Medical Devices

Integra LifeSciences; Mansfield (MA); On-site; USD 71,000 - 98,000; Full time

Job summary

Integra LifeSciences in Mansfield, MA is seeking a Process Engineer II to understand, optimize, and sustain manufacturing processes using lean and six-sigma methods. You will improve layouts, workflows, and equipment while ensuring GMP, ISO, and regulatory compliance across the value stream.

You will collaborate with EHS, product development, and quality teams, perform validations (IQ/OQ/PQ/TMV), lead CAPAs, and drive cost and quality improvements through data-driven analysis and continuous

Qualifications

• Bachelor’s degree in Chemical Engineering, Mechanical Engineering, or related engineering discipline.
• Minimum of 3 years of industry experience in engineering; medical device experience is a plus.
• Lean Six Sigma Experience is a plus.
• Cleanroom manufacturing experience is a plus.
• Computer proficiency

Responsibilities

• Work cross-functional with EHS, product development, process technology, Centers of Excellence, facilities, quality, regulatory, planning, procurement to address process challenges, material changes, and 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 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, FMEA, and 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 KPIs.
• 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.

Skills

Lean Six Sigma

Statistical analysis

Process optimization

Quality improvement

Education

Bachelor's degree in Chemical/Mechanical Engineering

Tools

Computer proficiency

Job description

Integra LifeSciences in Mansfield, MA is seeking a Process Engineer II to understand, optimize, and sustain manufacturing processes using lean and six-sigma methods. You will improve layouts, workflows, and equipment while ensuring GMP, ISO, and regulatory compliance across the value stream.

You will collaborate with EHS, product development, and quality teams, perform validations (IQ/OQ/PQ/TMV), lead CAPAs, and drive cost and quality improvements through data-driven analysis and continuous