Process Engineer II - Lean Manufacturing (Medical Devices)

INTEGRA LIFESCIENCES PRODUCTION CORPORATION; Mansfield (MA); On-site; USD 71,300 - 97,750; Full time

Job summary

Integra LifeSciences is seeking a Process Engineer II in Mansfield, MA to understand, optimize, and sustain manufacturing processes using lean and six-sigma methodologies. You will drive improvements across lifecycle, quality, and cost while ensuring compliance with GMP, ISO standards, and regulatory requirements.

The role requires a Bachelor’s degree in engineering and at least 3 years in manufacturing engineering, preferably in the medical device sector, with strong problem-solving and

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, 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 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, 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 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.

Skills

Lean Six Sigma

Statistical analysis

Process optimization

Cross-functional collaboration

Education

Bachelor's degree in Chemical Engineering or Mechanical Engineering

Tools

Statistical Process Control (SPC)

Engineering Change Requests/Orders (ECR/ECO)

Job description

Integra LifeSciences is seeking a Process Engineer II in Mansfield, MA to understand, optimize, and sustain manufacturing processes using lean and six-sigma methodologies. You will drive improvements across lifecycle, quality, and cost while ensuring compliance with GMP, ISO standards, and regulatory requirements.

The role requires a Bachelor’s degree in engineering and at least 3 years in manufacturing engineering, preferably in the medical device sector, with strong problem-solving and