Process Engineer II - Lean Six Sigma for Med Devices

INTEGRA LIFESCIENCES PRODUCTION CORPORATION; Mansfield (MA); Sur place; USD 71 000 - 98 000; Plein temps

Avantages offerts par ce poste

medical

dental

vision

life insurance

short- and long-term disability

business accident insurance

group legal insurance

savings plan (401(k))

Résumé du poste

Integra LifeSciences Production Corporation in Mansfield, MA is seeking a Process Engineer II focused on optimizing and sustaining manufacturing processes using lean and six-sigma methodologies. You will develop end-to-end process understanding, support lifecycle management, and ensure compliance with GMP, ISO, and regulatory standards while driving efficiency and quality.

Key duties include cross-functional collaboration, executing engineering studies, validations, ECR/ECO, SPC analysis, CAPA,

Qualifications

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

Responsabilités

• 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 on cross-functional projects addressing quality, lifecycle management, and new product introductions.
• Execute engineering studies, IQ/OQ/PQ/TMV validations, and create equipment/process specifications and ECO/ECR documents.
• Conduct SPC analysis and trend process parameters to improve yields and reduce scrap; implement error-proofing.
• Perform investigations, non-conformances, FMEA, and CAPA; drive cost and reliability improvements.
• Complete time studies and align BOMs, work instructions, and routers with lifecycle from transfer to production.
• Monitor KPIs, develop improvement actions, and provide hands-on training for products/processes.

Connaissances

Lean Six Sigma

Process optimization

Statistical analysis

Cross-functional collaboration

Formation

Bachelor’s degree in Chemical or Mechanical Engineering

Outils

IQ/OQ/PQ

FMEA

CAPA

GMP knowledge

Description du poste

Integra LifeSciences Production Corporation in Mansfield, MA is seeking a Process Engineer II focused on optimizing and sustaining manufacturing processes using lean and six-sigma methodologies. You will develop end-to-end process understanding, support lifecycle management, and ensure compliance with GMP, ISO, and regulatory standards while driving efficiency and quality.

Key duties include cross-functional collaboration, executing engineering studies, validations, ECR/ECO, SPC analysis, CAPA,