Process Engineering Manager, Medical Devices

Integra LifeSciences Singapore Pte. Ltd.; United States; On-site; USD 73,000 - 102,000; Full time

Benefits offered by this job

401(k)

Job summary

Integra LifeSciences is seeking a Process Engineering Manager to lead the site value stream's equipment and processes, ensuring end-to-end understanding, lifecycle management, and sustained engineering changes. You will drive quality, productivity, and yield improvements while adhering to GMP, ISO 9001, ISO 13485, and other regulatory standards.

Under the Value Stream Manager, you will manage a team of engineers and technicians, oversee ECOs, CAPA, FMEA, IQ/OQ/PQ, and support validated process

Qualifications

• Engineering or technical degree required with leadership experience.
• Strong English communication skills (oral and written).
• Financial acumen and impact on P&L and investments.
• Proficient in MS Office and statistical analysis tools.
• Experience in regulated environments; medical device or pharma preferred.

Responsibilities

• Ensure safety and lead EH&S program engagement and investigations.
• Lead production-line support for new products, transfers, qualifications, validations, and yield improvements.
• Develop and manage a team of engineers and technicians, including planning and performance.
• Oversee engineering studies, ECOs, NCs, CAPA, FMEA, and validations (IQ/OQ/PQ).
• Drive project planning to ensure product safety, quality, durability, and regulatory compliance.
• Conduct investigations and CAPA activities under regulatory guidelines for medical devices.
• Collaborate with cross-functional teams to meet customer needs and drive lean improvements.
• Manage department COGS, BOMs, routers, and process instructions; align budgets and headcount.

Skills

Team leadership

English communication

Financial acumen

MS Office

Regulated environment

Self-motivated

Education

Engineering or Technical degree

Tools

ERP (SAP)

CRM platforms

MS Project

Jira

QMS platforms

Job description

Integra LifeSciences is seeking a Process Engineering Manager to lead the site value stream's equipment and processes, ensuring end-to-end understanding, lifecycle management, and sustained engineering changes. You will drive quality, productivity, and yield improvements while adhering to GMP, ISO 9001, ISO 13485, and other regulatory standards.

Under the Value Stream Manager, you will manage a team of engineers and technicians, oversee ECOs, CAPA, FMEA, IQ/OQ/PQ, and support validated process