Lead Process Engineer, Medical Devices & Manufacturing

Integra LifeSciences; Añasco (PR); 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) plan

Job summary

Integra LifeSciences is seeking a Process Engineering Manager to lead the site value stream’s equipment and processes. This role drives end-to-end process understanding, lifecycle management, and sustainability through strong engineering practices in support of supply chain integrity.

The manager oversees a team of engineers and technicians, ensuring safety, quality, and productivity while adhering to GMP, ISO 9001, ISO 13485, and other regulatory standards.

Qualifications

• Engineering or technical degree with leadership experience.
• Experience in regulated environments such as medical devices or pharma.
• Strong English communication and organizational skills.

Responsibilities

• Ensure safety via environmental, health, and safety program engagement.
• Lead production-line support including new products and transfers.
• Develop engineers and technicians; manage attendance and performance.
• Oversee ECOs, CAPAs, NCs, and validations (IQ/OQ/PQ).
• Plan and execute projects ensuring device safety, quality, and reliability.
• Investigate issues and provide practical manufacturing solutions under regs.
• Collaborate with cross-functional teams to meet customer needs and lean goals.
• Monitor cost of goods, BOMs, routers, and process instructions against budgets.
• Handle other duties as assigned.

Skills

Team leadership

Engineering degree

English communication

Financial acumen

MS Office

SAP

QMS

Regulated environment

Education

Engineering or Technical degree

Master's degree

Tools

SAP

CRM platforms

MS Project

Jira

Job description

Integra LifeSciences is seeking a Process Engineering Manager to lead the site value stream’s equipment and processes. This role drives end-to-end process understanding, lifecycle management, and sustainability through strong engineering practices in support of supply chain integrity.

The manager oversees a team of engineers and technicians, ensuring safety, quality, and productivity while adhering to GMP, ISO 9001, ISO 13485, and other regulatory standards.