Senior Process Engineer – MedTech, Lean Six Sigma

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

Job summary

Integra LifeSciences in Mansfield, MA is seeking a Senior Process Engineer to understand, optimize, and sustain manufacturing processes using lean and six sigma to improve efficiency and compliance with GMP, ISO 13485 and other regulations.

You will develop end-to-end process knowledge, validate new processes and equipment, support transfers, and drive cost and quality improvements while collaborating with Quality Assurance, Regulatory, Planning and Manufacturing teams.

Qualifications

• Bachelor's degree in Mechanical, Manufacturing, Materials or Biomedical Engineering is required.
• Minimum of 5 years of engineering industry experience is required.
• Experience in the medical device industry is required.
• Knowledge of GMPs, ISO 13485 Design Control, and Manufacturing Process IQ, OQ, PO qualifications as related to medical devices is required.
• Working knowledge in manufacturing processes such as metal processing, plastics processing, and mechanical assembly is required.
• Experience working in a cleanroom environment is preferred.

Responsibilities

• Works within cross-functional project teams to maintain and improve manufacturing processes.
• Designs, specifies, develops, and purchases manufacturing tooling, fixtures and equipment.
• Manages the implementation and validation of new or modified manufacturing processes and equipment.
• Support and guide transfers internally within plant and externally with suppliers.
• Writes and implements Manufacturing Procedures and Work Instructions.
• Creates, updates and maintains BOMs, Routers, and DMRs.
• Represents the Manufacturing Engineering group on strategic projects.

Skills

Lean Six Sigma

GMP/Quality systems

Manufacturing process design

Cross-functional collaboration

Education

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

Tools

SAP

MS Project

Jira

QMS platforms

Job description

Integra LifeSciences in Mansfield, MA is seeking a Senior Process Engineer to understand, optimize, and sustain manufacturing processes using lean and six sigma to improve efficiency and compliance with GMP, ISO 13485 and other regulations.

You will develop end-to-end process knowledge, validate new processes and equipment, support transfers, and drive cost and quality improvements while collaborating with Quality Assurance, Regulatory, Planning and Manufacturing teams.