What are the responsibilities and job description for the Manufacturing Engineer II position at Integra LifeSciences?
Changing lives. Building Careers.
Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what's possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care.
The Manufacturing Engineer will support engineering projects and operations focused on the design, development, and optimization of manufacturing processes for high-quality production. This role requires cross-functional collaboration, support in troubleshooting, process improvements, and validation activities to ensure production efficiency and regulatory compliance, in a regulated medical devices industry. The Manufacturing Engineer will be responsible for supporting cost reduction, quality improvements, and process efficiency while ensuring alignment with safety and quality standards.
ESSENTIAL DUTIES AND RESPONSIBILITIES
Develop, specify, purchase, and maintain manufacturing equipment, automation, tooling, and fixtures to support production needs.
Support engineering protocols for IQ, OQ, and PQ to ensure equipment and processes meet regulatory and performance standards.
Write and implement manufacturing procedures and work instructions to standardize processes, ensure quality control, and optimize production workflows.
Provide process and equipment engineering expertise to resolve manufacturing-related issues for existing products and processes.
Support change controls (ECOs), CAPAs, and NCs to address manufacturing and quality process issues.
Utilize Lean or Six Sigma methodologies to optimize processes, reduce costs, improve quality, and minimize waste.
Collaborate with R&D, Quality, and Operations teams to design and implement efficient and scalable manufacturing processes.
Ensure compliance with industry standards and regulations (e.g., ISO, FDA) in manufacturing processes.
Provides training and guidance to production and quality staff.
QUALIFICATIONS :
Bachelor's degree in engineering (Mechanical, Industrial, or related field) with 3 years of experience or equivalent education and years of experience.
Experience in a regulated industry such as medical devices or pharmaceuticals.
Experience with validation protocols (IQ, OQ, PQ) and equipment / process qualifications.
Expertise in Lean Manufacturing, Six Sigma, and other process improvement methodologies.
Experience in CAPA / NC investigations with understanding of root cause analysis and corrective action processes.
Excellent problem-solving skills, with the ability to work across multiple projects concurrently.
Strong communication, team-building, and cross-functional coordination skills, with experience working in cross-functional teams.
Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status.
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