Principal Process Engineer

Davita Inc.; Austin (TX); On-site; USD 90,000 - 130,000; Full time

Job summary

A leading medical device company in Austin is seeking a Process Engineer to support manufacturing operations. The role involves process improvements, designing test equipment, and ensuring compliance with engineering standards. Candidates must have a Bachelor's degree in Engineering and 10 years of experience in the medical device sector.

Qualifications

• Minimum 10 years' experience in medical device or related engineering.
• Design skills using CAD software.
• Green Belt in 5S/Lean Manufacturing required.

Responsibilities

• Collaborates with quality for materials specifications.
• Designs and builds custom process and test equipment.
• Leads CAPA investigations and serves as Subject Matter Expert during audits.

Skills

Computer Aided Design

5S

Lean Manufacturing

Education

Bachelor's Degree in Engineering (Mechanical, Chemical, Biomedical or related)

Job description

Description

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 1,600 employees globally and manufacturing sites in Atlanta, Austin, and Hechingen, Germany, Artivion serves healthcare professionals in over 100 countries. For more details on the On-X Mechanical Heart Valve, click here.

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:

• Collaborates with quality to determine and develop needed custom and stock materials and/or parts specifications.


• Designs and builds custom process and test equipment, including development and revision of equipment and part drawings using CAD software.


• Coordinates complex Engineering Change Notices for design changes, including materials and process changes.


• Provides corporate-wide expertise in the troubleshooting of complex equipment and process issues. Recommends final disposition if escalated.


• Designs, develops, programs and maintains PLC controlled processes. Identifies, evaluates and establishes optimal parameters for OEM equipment software.


• Identifies innovative major process improvements, including new equipment and process optimization, and leads project teams from identification to execution. Identifies gaps in processes, develops project plan, costs and resources.


• Provides in-depth technical support when dealing with suppliers of key components and equipment.


• Leads start-up, debug and implementation of new equipment. Develops and executes process evaluations and validations, collaborating with other functional groups.


• Leads creation and improvement of Operations documentation. Reviews and approves all edits.


• Maintains expert knowledge of pertinent Manufacturing Technologies and makes recommendations accordingly to Senior Management.


• Leads CAPA investigations and completes/assigns deliverables to complete investigation.


• Serves as Subject Matter Expert (SME) during audits.


• Performs additional duties as assigned by Manager.

Qualifications:

• Bachelor's Degree in Engineering (Mechanical, Chemical, Biomedical or related field of engineering).


• Minimum 10 years' experience encompassing medical device, tissue product or related engineering experience (Minimum 8 years with Masters in Engineering).


• Computer Aided Design skills required


• Green Belt in 5S/Lean Manufacturing required

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.