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Product Engineer I

2 months ago

Austin, United States CryoLife Full time
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:

POSITION OBJECTIVE:

As a key member of the engineering team at Artivion, you will provide essential engineering support for our products throughout all phases of development and manufacturing. Your role will involve bringing new products to market, ensuring they meet functionality requirements, are manufactured efficiently, and comply with regulatory standards. Additionally, you will refine existing product processes to enhance efficiency while maintaining the highest quality standards. You will coordinate engineering changes, offer design support, and play a critical role in packaging, labeling testing, and updates. Your efforts will be crucial in resolving production challenges and ensuring business continuity for assigned products.

Principal Responsibilities:

  • Support Senior Engineers: Assist in the development and review of engineering drawings, specifications, procedures, and tooling for the production and inspection of assigned products.
  • Process Development: Coordinate the creation and implementation of manufacturing processes to ensure successful product manufacturing.
  • Quality Assurance: Ensure that assigned processes produce components or sub-assemblies that meet all applicable drawings, specifications, and procedures.
  • Evaluation and Validation: Support the evaluation and validation of manufacturing processes and packaging.
  • Problem Solving: Analyze manufacturing-related issues and propose effective solutions for assigned products.
  • Subcontractor Coordination: Manage activities with manufacturing subcontractors to maintain quality and efficiency.
  • Engineering Change Management: Coordinate Engineering Change Notices and assess their impact on functionality, performance, and safety requirements.
  • Nonconformance Resolution: Assist in resolving nonconformances and addressing minor CAPA (Corrective and Preventive Actions) items.
  • Product Tuning: Conduct tuning for coated leaflets as needed.
  • Documentation Maintenance: Support the upkeep of design files and production documentation for assigned product lines.
Other responsibilities as assigned.

Key Result Areas:

  1. Product Success: Ensure the successful production of assigned products.
  2. Process Improvement: Reduce manufacturing errors, improve yields, and streamline cycle times.
  3. Audit Success: Contribute to the successful completion of audits.
  4. Supplier Continuity: Address supplier continuity issues to prevent product run-out.
  5. Continuous Improvement: Drive continuous process improvement efforts.

Qualifications:
  • Education: Bachelor's degree in Engineering (Mechanical, Chemical, Biomedical, Industrial, or a related field).
  • Experience: 0-2 years of experience in medical device engineering or a related field.
  • Skills: Familiarity with Computer-Aided Design (CAD) is preferred.
Additional Competencies:
  • Ability to follow and execute instructions for engineering changes.
  • Knowledge of ANSI drawing standards and familiarity with applicable ISO and FDA standards.
  • Strong problem-solving skills with the ability to identify root causes and develop practical solutions.
  • Capable of managing multiple tasks efficiently and effectively.
  • Excellent verbal and written communication skills.
  • Attention to detail and a commitment to producing high-quality results.
  • Strong interpersonal skills and the ability to thrive in a collaborative team environment.
Benefits:
  • Competitive compensation and benefits package.
  • Opportunities for professional growth and development.
  • Positive work environment with a focus on innovation and continuous improvement.