Lead Process Engineering for Medical Devices

INTEGRA CI INC; United States; On-site; USD 73,000 - 102,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Life insurance

Disability insurance

401(k) Savings plan

Job summary

Integra LifeSciences is seeking a Process Engineering Manager to lead a team of engineers and technicians in a regulated medical device manufacturing setting. You will oversee end-to-end process development, qualifications, and continuous improvement to ensure safety, product quality, and cost targets.

The role requires experience in ECOs, CAPAs, and validations (IQ/OQ/PQ) with strong cross-functional collaboration across engineering, quality, and operations.

Qualifications

• Engineering or technical degree with leadership experience in a regulated manufacturing environment.
• Experience managing a team of engineers and technicians; strong cross-functional collaboration.
• Familiarity with GMP, ISO 9001/13485 and medical device regulations.

Responsibilities

• Lead safety and EHS program engagement across the value stream.
• Oversee training, compliance, and skill development of team members.
• Guide production line operations, transfers, qualifications, and validations.
• Develop staffing plans, performance reviews, and succession planning.
• Manage ECOs, CAPAs, FMEA, IQ/OQ/PQ, and process validations.
• Ensure cost of goods and budgeting alignment with financial targets.
• Collaborate with cross-functional teams to meet customer needs and drive improvements.
• Monitor process capability metrics and drive yield improvements.

Skills

Leadership

Communication (English)

Financial acumen

MS Office

Statistical analysis

Education

Engineering or Technical degree

Tools

SAP

MS Project

Jira

Job description

Integra LifeSciences is seeking a Process Engineering Manager to lead a team of engineers and technicians in a regulated medical device manufacturing setting. You will oversee end-to-end process development, qualifications, and continuous improvement to ensure safety, product quality, and cost targets.

The role requires experience in ECOs, CAPAs, and validations (IQ/OQ/PQ) with strong cross-functional collaboration across engineering, quality, and operations.