What are the responsibilities and job description for the Senior Manufacturing Engineer position at Integra LifeSciences?
Integra LifeSciences Senior Manufacturing Engineer Boston, Massachusetts Apply Now
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.
Have you got what it takes to succeed The following information should be read carefully by all candidates.
The Senior Manufacturing Engineer will lead and support engineering projects and operations focused on the development, and optimization of manufacturing processes for high-quality production. This role requires technical expertise, cross-functional collaboration, and leadership in troubleshooting, process improvements, and validation activities to ensure production efficiency and regulatory compliance in a medical devices regulated industry. The Senior Manufacturing Engineer will be responsible for identifying opportunities for cost reduction, quality improvements, and process efficiency while ensuring alignment with safety and quality standards.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Provide technical leadership in the design, validation, and troubleshooting of production equipment and processes.
- Develop, specify, purchase, and maintain manufacturing equipment, automation, tooling, and fixtures to support production needs.
- Create and execute engineering protocols for IQ, OQ, and PQ to ensure equipment and processes meet regulatory and performance standards.
- Lead test method development protocol and execution.
- Write and implement manufacturing procedures and work instructions to standardize processes, ensure quality control, and optimize production workflows.
- Act as a recognized technical expert, providing process and equipment engineering expertise to resolve manufacturing-related issues for existing products and processes.
- Lead and / or support change controls (ECOs), CAPAs, and NCs to address manufacturing and quality process issues.
- Own NC's and CAPAs driving completion in a timely and compliant manner.
- Drive process improvement initiatives, utilizing 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.
- Mentor and train junior engineers and production staff, sharing best practices and technical expertise to improve team capabilities.
BASIC QUALIFICATIONS
PREFERRED QUALIFICATIONS
TOOLS AND EQUIPMENT USED
Ability to utilize a computer, telephone, smartphone as well as other general office equipment.
PHYSICAL REQUIREMENTS
The physical requirements listed in this section include, but are not limited to, the motor / physical abilities and skills required of position in order to successfully undertake the essential duties and responsibilities of this position. In accordance with the Americans with Disabilities Act (ADA), reasonable accommodations may be made to empower individuals with disabilities to undertake the essential duties and responsibilities of the position.
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