Senior Product Engineer

Senior Product Engineer

Headquartered in suburban Atlanta, Georgia, Artivion, Inc. specializes in developing innovative medical devices aimed at addressing challenging cardiac and vascular conditions. Our Austin facility houses a diverse team dedicated to producing the On-X Mechanical Heart Valves. With over 1,400 employees globally and manufacturing sites in Atlanta, Austin, and Hechingen, Germany, Artivion serves healthcare professionals in over 100 countries. For more details, visit our website at www.artivion.com.

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; and troubleshoot and resolve production problems for assigned products.

• Interface with Production, Product Development and other appropriate functions to fully understand and suggest improvements to functionality, performance, and safety requirements of 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
• Coordinate work among Production, Quality Control, Process Engineering, and Quality Assurance to assure that required manufacturing and inspection steps for successful & efficient production of assigned products are properly defined, integrated, implemented & verified / validated
• Design, provide or review needed engineering drawings, specifications, procedures, methods, tooling, fixturing, or gaging for processing and inspecting assigned products
• Determine disposition of discrepant materials or components
• Ensure that acceptable raw materials and components required for supporting in-house production levels are received. This includes identifying new vendors and communicating engineering, quality, delivery, and regulatory requirements.
• Analyze complicated Manufacturing related problems of assigned products, propose possible solutions and coordinate implementation of best solutions
• Develop, review and update risk assessment for assigned products
• Suggest and implement production changes to improve reliability, reduce cycle times and enhance yields
• Drive activities with manufacturing subcontractors to define and design processes and optimize results
• Communicate and provide expert opinion on technical product status to management, to include yield, manufacturing and quality issues
• Maintain expert knowledge of pertinent Manufacturing Technologies and disseminate this information as requested to various engineering and production groups

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

Provide various product cost and implementation schedules

Design and optimize substrate designs for complex carbon coated components

Travel to vendors, trade shows and between Artivion facilities, possibly overseas

Perform additional duties that may be assigned by Supervisor

Relate to other people beyond giving and receiving instructions : (a) can get along with co-workers or peers without exhibiting behavioral extremes; (b) perform work activities requiring negotiating, instructing, persuading or speaking with others; and (c) respond appropriately to criticism from a supervisor

Manage time effectively; prioritize and make good business judgments and decisions in relationship to efficiency

Other responsibilities as assigned.

Minimum of a Bachelors degree, Engineering strongly preferred

Typically requires 5 - 8 years experience Engineering experience, Class III Medical Devices strongly preferred

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

Green Belt in 5S / Lean Manufacturing preferred

Self-starter with strong leadership, communication skills and demonstrated problem solving ability

Strong computer skills including at minimum, be adept in use of MS Office 2000 or later, internet, and electronic mail

Strong interpersonal and communication skills

Comprehensive Medical, Dental, and Vision

Life Insurance

Supplemental Benefits

401(k) with both Traditional and Roth options available

Employee Stock Purchase Plan (ESPP)

10 Paid Company Holidays

Competitive PTO plan

Tuition Reimbursement

Equal Employment Opportunity Employer (EEO) : We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other protected status under applicable law.