Senior Process Engineer II | Lean Six Sigma (Medical Devices)

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

Job summary

Integra LifeSciences Corporation in Mansfield, MA seeks a Process Engineer II to optimize and sustain manufacturing processes using lean and six-sigma tools. You will support lifecycle management, DOE studies, and cross-functional projects to improve efficiency and quality.

A BS in engineering and 3 years’ experience, with GMP exposure, are preferred. Applicants should be adept at cross-functional collaboration, process validation, and data-driven decision making, with a focus on cost and

Qualifications

• Bachelor’s degree in Chemical or Mechanical Engineering or related field.
• Minimum 3 years in engineering; medical device experience is a plus.
• Lean Six Sigma experience is a plus; cleanroom experience is a plus.

Responsibilities

• Work cross-functionally with EHS, product development, process technology, CoE's, facilities, quality, regulatory, planning and procurement on process challenges and lifecycle changes.
• Represent value stream teams in site and enterprise projects addressing quality improvements and new product introductions.
• Execute engineering studies, IQ/OQ/PQ/TMV validations, and engineering change requests/orders for equipment and processes.
• Conduct statistical process control analysis and trend process parameters to improve yields and reduce scrap.
• Perform technical investigations, non-conformance, FMEA, and CAPA activities.
• Drive process, quality, reliability and cost improvements using lean six-sigma and advanced tech.
• Conduct time studies and align BOMs, work instructions, and routers with process to ensure cost accuracy.
• Monitor performance metrics for value streams and implement KPI-driven improvements.
• Develop hands-on training programs for product/process/equipment.
• Participate in cross-functional project teams and perform other duties as assigned.

Skills

Lean Six Sigma

Statistical analysis

Cross-functional collaboration

Education

Bachelor's degree in Chemical Engineering

Bachelor's degree in Mechanical Engineering

Related engineering discipline

Tools

IQ/OQ/PQ validation

CAPA

Process validation

Job description

Integra LifeSciences Corporation in Mansfield, MA seeks a Process Engineer II to optimize and sustain manufacturing processes using lean and six-sigma tools. You will support lifecycle management, DOE studies, and cross-functional projects to improve efficiency and quality.

A BS in engineering and 3 years’ experience, with GMP exposure, are preferred. Applicants should be adept at cross-functional collaboration, process validation, and data-driven decision making, with a focus on cost and