Process Engineer II - Lean Medical Device Innovator

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

Job summary

Integra LifeSciences in Mansfield, MA is seeking a Process Engineer II to optimize and sustain manufacturing processes using lean and six sigma tools. You will develop end-to-end process understanding and manage lifecycle changes for equipment and processes.

Collaborate with EHS, product development, quality, and operations; perform IQ/OQ/PQ validations, CAPA investigations, time studies, and KPI monitoring to improve yields and reduce scrap.

Qualifications

• Bachelor’s degree in Chemical/Mechanical Engineering or related field.
• Minimum of 3 years in engineering; medical device experience a plus.
• Lean Six Sigma experience is a plus; GMP/regulated environment knowledge preferred.

Responsibilities

• Execute engineering studies and validations (IQ/OQ/PQ/TMV) for equipment and processes.
• Analyze SPC data, trend process parameters, and drive yield improvements.
• Lead CAPA investigations and FMEA to address root causes of quality issues.
• Develop end-to-end process understanding, lifecycle, and sustaining changes.
• Collaborate across EHS, product development, facilities, QA, and regulatory teams.
• Align BOMs, work instructions, and routers with process improvements.

Skills

Process engineering

Lean Six Sigma

Statistical analysis

CAPA

FMEA

IQ/OQ/PQ

TMV validations

Time studies

Education

Bachelor's degree in Chemical Engineering

Bachelor's degree in Mechanical Engineering

Engineering degree or related discipline

Job description

Integra LifeSciences in Mansfield, MA is seeking a Process Engineer II to optimize and sustain manufacturing processes using lean and six sigma tools. You will develop end-to-end process understanding and manage lifecycle changes for equipment and processes.

Collaborate with EHS, product development, quality, and operations; perform IQ/OQ/PQ validations, CAPA investigations, time studies, and KPI monitoring to improve yields and reduce scrap.