Director, Process Engineering

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Austin, TX, USA
In-Office
Biotech
The Role

Company Overview:

Headquartered in suburban Atlanta, Georgia, Artivion, Inc. is a medical device company focused on developing simple, elegant solutions that address cardiac and vascular surgeons’ most difficult challenges in treating patients with aortic diseases. Artivion’s four major groups of products include: aortic stent grafts, surgical sealants, On-X mechanical heart valves, and implantable cardiac and vascular human tissues. Artivion has over 1,400 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. For additional information about Artivion, visit our website, www.artivion.com.

Position Overview:

The Director, Process Engineering, will provide leadership for process engineering and continuous improvement for all site manufacturing operations.  The Director will oversee engineering efforts to expand production capacity, improve manufacturing processes and implement new technologies.  The Director will guide their team to ensure process specifications are met and manufacturing goals are achieved.  Responsibility includes technical oversight of on-site manufacturing equipment and manufacturing materials.

Responsibilities:

  • Drive achievement of continuous improvement for manufacturing processes through innovative solutions and incorporation of technological advancements.
  • Spearhead engineering efforts to resolve process issues by challenging team members to develop practical, innovative solutions. 
  • Provide rapid response to address down equipment in coordination with maintenance and facilities team.
  • Direct and coordinate team efforts to implement and qualify both new and relocated equipment.
  • Support implementation and employment of MES to monitor process performance and identify opportunities for improvement. Reduce product cost by improving yields and process efficiencies.
  • Manage engineering support to identify and support material vendors, including qualifications associated with manufacturing material changes.
  • Oversee component fitup and targeting processes to ensure stable production flow and achievement of production volume goals.
  • Incorporate AI tools into engineering workflows to accelerate productivity.
  • Provide financial justification for large projects by assessing project costs, expected returns and ROI analysis.
  • Coordinate with other department leaders to plan, budget and prioritize projects, ensuring critical project objectives are achieved.
  • Coordinate process engineering responses for Non-Conformances, CAPA, complaints, technical questions and regulatory reviews.
  • Instill and promote a culture of engineering excellence.  Establish a work environment where engineering team members are motivated and enthusiastic to work at Artivion. 
  • Provide effective training, coaching, mentoring, and performance feedback to managers and engineers.  Responsible for performance reviews, job promotions and salary recommendations for personnel within the department.
  • Develop and meet department budgets and submit Budget Change Requests when necessary.
  • Maintain the highest ethical standards, even when challenged from above.

Qualifications:

  • Bachelor’s Degree in Engineering or related field, Masters or MBA preferred
  • 10+ years’ experience within medical device or related manufacturing operation
  • 5+ years’ management experience with direct reports
  • Lean Six Sigma Black Belt Certified
  • Excellent teamwork skills and motivation to help others
  • Must have excellent oral and written communication skills
  • Comprehends Mechanical & Electrical drawings for Equipment and Facilities
  • Inherent vision for process improvements
  • Ability to manage and prioritize multiple tasks to completion
  • Ability to hire and retain talented personnel
  • Ability to make decisions quickly in stressful situations
  • Ability to anticipate needs and ensure they are planned for
  • Ability to motivate staff to achieve excellence
        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.

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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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