Artivion, Inc. · 2 hours ago
Process Engineer III (Kennesaw, GA)
Kennesaw, GA
Full-time
Onsite
Mid, Senior Level
4+ years expArtivion, Inc. is a medical device company focused on developing solutions for cardiac and vascular surgeries. The Process Engineer III is responsible for providing engineering support for manufacturing, initiating process improvements, and collaborating on new product launches.
Biotechnology
Responsibilities
Coordinate and manage multiple, often concurrent, Engineering Changes for critical process and design changes throughout the product life cycle
Works closely with Operations, Quality Engineering, R&D, Quality Assurance, and Regulatory to conceptualize, develop, and implement engineering changes for raw materials, tooling, manufacturing processes and equipment
Lead business continuity and second-source changes to prevent line down situations by identifying, sourcing, qualifying, and implementing alternative materials or procedures
Author and execute technical studies. Collect, statistically analyze, and develop report packages to support validations and engineering studies
Serve as SME for commercial products, and respective manufacturing processes. Assess impacts of changes on DV&V testing (shelf life and distribution)
Lead shelf life and simulated distribution studies for commercial products, and ensure studies comply to Artivion policies and effective standards
Serve as SME for equipment, responsible for User Requirement Specification, equipment start-up, debug, and qualification (IQ/OQ) of manufacturing and facility equipment. Troubleshoot existing equipment and processes. Identify and coordinate implementation of repairs
Identify, develop, and implement new or improved manufacturing processes and equipment. Design and execute test plans to identify critical factors (i.e. DOE, MSA), assess upstream and downstream impacts of changes, and expand process knowledge. Determine budget requirements and ROI
Develop and implement test methods for raw materials and commercial products. Ensure test methods comply to Artivion policies and industry standards
Maintain and expand in-depth knowledge of pertinent Manufacturing Technologies, and industry standards, and disseminate this information as requested to engineering and operations groups
Revise drawings of intermediate and final products, manufacturing tools, and other drawings using CAD software
Maintain Device Master Records for commercial products
Assist in audit deliverables and/or CAPA investigations and deliverables as assigned by management
Qualification
Required
Bachelor's degree in Engineering (Mechanical, Chemical, Biomedical or related field of engineering)
Typically requires 4-6 years of medical device, tissue product or related engineering experience (2-4 years with Masters in Engineering)
Comfortable commuting to Kennesaw location 4 days per week
Preferred
Familiarity with Computer Aided Design (CAD) preferred
Experience with MiniTab statistical software
Green Belt in 5S/Lean Manufacturing preferred
Experience with tissue processing and/or chemical processing preferred
Company
Artivion, Inc.
Artivion is a leader in the manufacturing, processing, and distribution of medical devices and implantable tissues used in cardiac and vascular surgical procedures focused on aortic repair.
1001-5000 employees
Funding
Current Stage
Late StageLeadership Team
Pat Mackin
President & CEO
Ashley Lee
EVP, COO & CFO
Company data provided by crunchbase