Process Engineer II

Posted 8 Days Ago
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Austin, TX, USA
In-Office
Mid level
Biotech
The Role
The Process Engineer II provides engineering support for manufacturing, initiates process improvements, ensures SOP adherence, and collaborates on new product launches.
Summary Generated by Built In

Company Overview

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.


Position Objective:

Responsible for providing process engineering support for all product manufacturing departments. Supports manufacturing operations to ensure consistent adherence to the standard operating procedures and business continuity. Initiates process improvement initiatives to improve the efficiency of current manufacturing processes, as well as develop new processes to improve manufacturing efficiency. Supports new product launches by collaborating with other functional areas and providing process engineering expertise during the implementation of processes or equipment.


Responsibilities: 

  • Edits and updates material and part specifications.  
  • Revises equipment and part drawings using CAD software.
  • Coordinates Engineering Change Notices for design changes, including materials and process changes, with managerial oversight.
  • Troubleshoots equipment and processes through physical inspection/diagnosing of parts.  Orders replacement parts as needed.  
  • Maintains and assists in development of PLC controlled processes.  Evaluates and implements appropriate parameters for OEM equipment software. 
  • Leads tasks or sub-projects within product and process improvement initiatives. 
  • Provides technical support when dealing with suppliers of key components and equipment. 
  • Provides engineering support for new equipment start-up, debug and process validation.  As required, conducts process evaluations and validations under guidance of senior engineers and quality engineering. 
  • Incorporates best practices in the creation and improving of Operations documentation. 
  • Coordinates product and packaging distribution and shelf life tests under guidance of senior engineers. 
  • Assist in audit/CAPA deliverables as assigned by management.  
  • Perform additional duties as assigned by Manager. 
  • Successful implementation of new products and processes. 
  • Reduction of manufacturing errors and improvement of yields and cycle times. 
  • Successful completion of audits. 
  • Provide knowledge and feedback to the production team for the successful implementation of new processes or equipment. 
  • Addressing supplier continuity issues to prevent product run-out. 
  • Continuous Process Improvement. 
  • Knowledge of how to conceptualize process workflows. 
  • Ability to follow, execute, convey moderately complex instruction to make engineering updates 
  • Demonstrates the ability to manage multiple tasks to completion. 
  • Demonstrates the ability to analyze complex problems and develop practical solutions. 
  • Demonstrates good verbal and written communication skills. 
  • Demonstrates attention to detail and the ability to produce results. 
  • Is considered emerging subject matter expert and resource for junior level employees 
  • Demonstrates good interpersonal skills in a team environment. 

                                                     Other responsibilities as assigned.

                                                   

                                                  Qualifications:

                                                    • Bachelor’s degree in Engineering (Mechanical, Chemical, Biomedical, Industrial or related field of engineering).

                                                    • Typically requires 2-5 years of medical device, tissue product or related engineering experience (1-3 years with Masters in Engineering).

                                                    • Familiarity with Computer Aided Design (CAD) preferred

                                                    • Green Belt in 5S/Lean Manufacturing preferred


                                                    Benefits:

                                                    • 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.

                                                    Equal Opportunity Employer
                                                    This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.

                                                    Top Skills

                                                    Cad
                                                    Plc
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                                                    The Company
                                                    HQ: Kennesaw, GA
                                                    740 Employees
                                                    Year Founded: 1984

                                                    What We Do

                                                    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. Our purpose is to develop simple, elegant solutions that address cardiac and vascular surgeons’ most difficult challenges in treating patients with diseases of the aorta and deliver breakthrough technologies of unsurpassed quality that have far-reaching impact. Our decades of expertise in treating aortic diseases—coupled with our recent acquisitions and partnerships—have empowered us to offer cardiac and vascular surgeons a suite of aortic-centric solutions such as cryopreserved cardiac and vascular allografts, surgical sealants, prosthetic heart valves, and aortic stents and stent-grafts. Artivion has over 1,250 employees worldwide with sales representation in over 100 countries. The Company has manufacturing facilities located in Atlanta, Georgia, Austin, Texas, and Hechingen, Germany. Additionally, it has sales and distribution offices in various countries throughout Europe, Asia, and South America.

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