Process Engineer II - Lean Medical Device Manufacturing

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 within a value stream using lean and six sigma tools.

You will develop end-to-end process understanding, address lifecycle management and sustaining engineering changes, and ensure compliance with GMP, ISO, and regulatory standards.

This role collaborates across functions to improve yield, reduce scrap, and drive cost improvements through data-driven methods.

Qualifications

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

Responsibilities

• 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 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 (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.
• Complete other job-related duties as assigned.

Skills

Lean Six Sigma

Computer proficiency

Statistical analysis

Education

Bachelor’s degree in Chemical Engineering, Mechanical Engineering, or related engineering discipline

Tools

IQ/OQ/PQ/TMV validations

Engineering Change Requests/Orders (ECR/ECO)

Job description

Integra LifeSciences in Mansfield, MA is seeking a Process Engineer II to understand, optimize, and sustain manufacturing processes within a value stream using lean and six sigma tools.

You will develop end-to-end process understanding, address lifecycle management and sustaining engineering changes, and ensure compliance with GMP, ISO, and regulatory standards.

This role collaborates across functions to improve yield, reduce scrap, and drive cost improvements through data-driven methods.