Senior Process Engineer: Medical Device, Lean Six Sigma

Integra LifeSciences Corporation; Mansfield (MA); On-site; USD 81,650 - 112,700; Full time

Job summary

Integra LifeSciences Corporation in Mansfield, MA invites a Senior Process Engineer to optimize and sustain manufacturing processes within a value stream. You will lead cross-functional teams, implement Lean Six Sigma, and drive cost and quality improvements in a medical device environment.

Requires a Bachelor’s in engineering, 5+ years in industry, GMP/ISO13485 knowledge, and on-site presence in Mansfield. Cleanroom experience preferred; travel up to 10% may be needed.

Qualifications

• Bachelor's degree in Mechanical/Manufacturing/Materials or Biomedical Engineering.
• Minimum of 5 years of engineering industry experience.
• Experience in the medical device industry is required.
• Knowledge of GMPs, ISO 13485 Design Control, and Manufacturing Process IQ/OQ/PQ qualifications.
• Cleanroom experience preferred.

Responsibilities

• Understand, optimize, and sustain manufacturing processes within a value stream.
• Lead cross-functional teams to improve processing, layout, workflow, and costs.
• Design, specify, develop, and purchase tooling and equipment for manufacturing.
• Validate new/modified processes and support transfers with suppliers.
• Create and maintain manufacturing procedures, BOMs, routers, and DMRs.

Skills

Lean Six Sigma

Cross-functional teamwork

Regulatory compliance

Process optimization

Statistical analysis

Communication

Education

Bachelor's degree in Mechanical/Manufacturing/Materials or Biomedical Engineering

Tools

CAD

Minitab

ERP systems (SAP)

Job description

Integra LifeSciences Corporation in Mansfield, MA invites a Senior Process Engineer to optimize and sustain manufacturing processes within a value stream. You will lead cross-functional teams, implement Lean Six Sigma, and drive cost and quality improvements in a medical device environment.

Requires a Bachelor’s in engineering, 5+ years in industry, GMP/ISO13485 knowledge, and on-site presence in Mansfield. Cleanroom experience preferred; travel up to 10% may be needed.