Process Engineer II: Lean Six Sigma for Medical Devices

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

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Life insurance

Disability insurance

401(k) plan

Job summary

Integra LifeSciences in Mansfield, MA, is seeking a Process Engineer II to understand, optimize, and sustain manufacturing processes within a value stream. You will work cross-functionally with EHS, product development, process technology, CoE, facilities, quality, regulatory, planning and procurement to address process challenges and lifecycle changes.

Responsibilities include executing IQ/OQ/PQ/TMV validations, preparing Engineering Drawings, ECR/ECOs, performing SPC analysis, reducing scrap,

Qualifications

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

Responsibilities

• Work cross-functionally with EHS, product development, process technology, Centers of Excellence (CoE's), facilities, quality, regulatory, planning, and 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, ECR/ECOs, 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 yields, reduce 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 using lean six-sigma tools and methodologies.
• Conduct time studies, process evaluations, and technical evaluations to align BOMs, work instructions, and routers with process to ensure cost accuracy from product transfer through lifecycle.
• Monitor performance metrics for value streams and develop improvement actions to meet KPI targets.
• Develop hands-on training programs for product/process/equipment.
• 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

GMP

Education

Bachelor’s degree in Chemical or Mechanical Engineering

Job description

Integra LifeSciences in Mansfield, MA, is seeking a Process Engineer II to understand, optimize, and sustain manufacturing processes within a value stream. You will work cross-functionally with EHS, product development, process technology, CoE, facilities, quality, regulatory, planning and procurement to address process challenges and lifecycle changes.

Responsibilities include executing IQ/OQ/PQ/TMV validations, preparing Engineering Drawings, ECR/ECOs, performing SPC analysis, reducing scrap,