Senior Process Engineer

JOTEC GmbH 2016; Austin (TX); On-site; USD 80,000 - 120,000; Full time

Job summary

A leading company specializing in innovative medical devices is seeking an experienced engineer for their Austin facility. The role involves supporting product development, managing complex processes, and ensuring compliance with regulatory standards. Candidates should possess strong problem-solving abilities and relevant experience in medical or highly regulated fields.

Qualifications

• Master’s degree with 5 years of experience or Bachelor’s with 7-8 years.
• Experience in medical device or highly regulated field required.
• Strong leadership and communication skills required.

Responsibilities

• Coordinate and manage new complex process introduction schedules.
• Work closely with product engineers during development phases.
• Validate and document process control systems and equipment.

Skills

Problem Solving

Communication

Leadership

Interpersonal Skills

Education

Master’s degree

Bachelor’s degree

Tools

SolidWorks

Visual Basic

CMM programming

MS Office

Microsoft Outlook

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:

Provide expert engineering support for a wide range of products through all phases of product development and manufacturing; being responsible for development, implementation, and support of various processes pertaining to the manufacture and quality control of mechanical heart valves, OEM products, and new products.

Responsibilities:

• Coordinate and manage new complex process introduction schedule and activities, and cross-product issues throughout the product life cycle.
• Work closely with product engineers and product development engineers during Design Control phases to conceptualize, develop and implement processes. Responsibility includes debugging processes, reliability qualification, cycle time optimization and yield enhancement.
• Validate and document intricate process control systems, testing equipment, and manufacturing equipment using methods such as SPC, process capability, R&R and software test cases to satisfy GMP and FDA requirements.
• Coordinate and lead the identification, development and implementation of new or improved product manufacturing and inspection processes.
• Communicate technical product status to management, including executive level. These can include new or existing processes.
• Support Product Engineering, Product Development, Production, Quality Control, Quality Assurance, and Regulatory Affairs to assure assigned processes successfully produce components or sub-assemblies that conform to applicable drawings, specifications, and/or procedures.
• Maintain and expand in-depth knowledge of pertinent Manufacturing Technologies and disseminate this information as requested to various engineering and production groups.
• Develop, implement and maintain complex PLC controlled processes, including design, PLC programming and development of monitoring methods.
• Stay current with various CAD, programming, inspection, and manufacturing system technologies and philosophies
• Provide cost and return on investment estimates for new equipment
• Perform additional duties that may be assigned by Supervisor
• Support and improve ongoing manufacturing processes
• Develop software or work with IT to develop software systems and databases
• 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

Qualifications:

• Master’s degree with 5 years of equivalent experience, or Bachelor’s degree with 7-8 years of equivalent experience or 20+ years of equivalent experience without a degree
• Experience in medical device or another highly regulated field, required
• Detailed understanding of diagnostic, product test, failure analysis, and debug techniques.
• Proven ability to take complex process designs into production.
• Solid understanding of circuit design, as well as fault modeling and isolation.
• Experienced with CAD software, preferably SolidWorks
• Experience with Visual Basic and CMM programming preferred
• Green Belt in 5S/Lean Manufacturing preferred
• Self-starter with strong leadership, communication skills and proven problem solving ability
• Strong interpersonal and communication skills
• Ability to read, analyze, interpret and follow written instructions
• Ability to interpret and follow oral instructions
• Ability to work in a team environment to achieve a common goal
• Strong computer skills including at minimum, be adept in use of MS Office and Microsoft Outlook
• Demonstrated ability to define problems, collect data, analyze information, establish facts, and draw valid conclusions.

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.