MedTech Process Engineer II: Lean & GMP Innovator

Integra LifeSciences Corporation; Mansfield (MA); On-site; USD 71,300 - 97,750; Full time

Job summary

Integra LifeSciences Corporation is seeking a Process Engineer II to understand, optimize, and sustain manufacturing processes within a value stream using lean and six-sigma tools. The role covers lifecycle management, sustaining engineering changes, and compliance with GMP, ISO 9001, ISO 13485, EU MDR, CMDR, and related regulations.

The candidate will collaborate across EHS, product development, and quality to drive process improvements, perform validations, and improve yield and cost metrics

Qualifications

• Bachelor’s degree in Chemical Engineering, Mechanical Engineering, or related engineering discipline.
• Lean Six Sigma experience is a plus.
• Experience with GMP/ISO/Regulatory compliance is beneficial.

Responsibilities

• Understand, optimize, and sustain manufacturing processes within a value stream.
• Lead cross-functional teams to address process challenges and lifecycle changes.
• Conduct process validations and CAPA analyses to improve yields and reduce scrap.

Skills

Lean Six Sigma

Cross-functional collaboration

Statistical analysis

Time studies

Education

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

Tools

Validation IQ/OQ/PQ/TMV

Job description

Integra LifeSciences Corporation is seeking a Process Engineer II to understand, optimize, and sustain manufacturing processes within a value stream using lean and six-sigma tools. The role covers lifecycle management, sustaining engineering changes, and compliance with GMP, ISO 9001, ISO 13485, EU MDR, CMDR, and related regulations.

The candidate will collaborate across EHS, product development, and quality to drive process improvements, perform validations, and improve yield and cost metrics