Artivion, Inc. is seeking an engineer to provide expert engineering support for medical devices, focusing on cardiac and vascular conditions. The role involves bringing new products online, ensuring functionality, manufacturability, and regulatory compliance, while also refining existing product processes to improve efficiency and quality, and troubleshooting production issues.
Requirements
- Needs to be well versed in A.N.S.I. drawing standards, CAD, mfg. processes, process control, engineering economics and project scheduling
- Detailed understanding of risk assessment and FMEA
- Demonstrated ability to take complex designs into production
- Experience in label and IFU design, including coordinating translations
- Strong computer skills including at minimum, be adept in use of MS Office 2000 or later, internet, and electronic mail
- Design and optimize substrate designs for complex carbon coated components
- Keep knowledge up to date regarding pertinent Manufacturing Systems and Processes; drawing standards; in house procedures, policies and specifications; GMP; ISO 9000 series and other appropriate regulatory requirements
Responsibilities
- Provide expert engineering support for a range of products through all phases of product development and manufacturing
- Bring new products on-line insuring desired functionality, efficient manufacture, and regulatory compliance
- Refine existing product processing in order to increase efficiency while maintaining required quality requirements
- Troubleshoot and resolve production problems for assigned products
- Coordinate and manage new product introduction schedule and activities, and cross-product issues throughout the product life cycle
- Identify, evaluate and coordinate the development and implementation of complex product manufacturing processes
- Design, provide or review needed engineering drawings, specifications, procedures, methods, tooling, fixturing, or gaging for processing and inspecting assigned products
Other
- Minimum of a Bachelors degree, Engineering strongly preferred
- Typically requires 5 - 8 years experience Engineering experience, Class III Medical Devices strongly preferred
- Travel to vendors, trade shows and between Artivion facilities, possibly overseas
- Self-starter with strong leadership, communication skills and demonstrated problem solving ability
- Strong interpersonal and communication skills
