Product Development Engineer

2 weeks ago

Austin, Texas, United States CryoLife Full time
Product Engineer II Job Description

The Product Engineer II plays a crucial role in ensuring the successful development and manufacturing of Artivion products. This position is responsible for providing engineering support throughout all phases of product development and manufacturing, ensuring that products meet desired functionality, efficiency, and regulatory compliance standards.

Key Responsibilities:
  • Assist in bringing new products online, ensuring efficient manufacture and regulatory compliance.
  • Refine existing product processing to increase efficiency while maintaining quality requirements.
  • Coordinate engineering changes and provide design support for assigned products.
  • Responsible for packaging and labeling testing and updates.
  • Resolve production problems and business continuity issues for assigned products.
Technical Skills:
  • Revises component and final drawings using CAD software.
  • Coordinates the development and implementation of product manufacturing processes.
  • Analyzes manufacturing-related problems and proposes solutions.
  • Leads tasks or sub-projects within product improvement initiatives.
  • Coordinates Engineering Change Notices for design changes, including packaging, labeling, and process changes.
  • Executes packaging, labeling, product stability, and other manufacturing validations under guidance of senior engineers and quality engineering.
  • Addresses nonconformances and minor CAPA items to determine root cause, recommend product disposition, and identify/implement appropriate actions.
  • Conducts tuning for coated leaflets and designs substrates for components requiring carbon coating.
  • Handles technical communication with manufacturing subcontractors.
Requirements:
  • Bachelor's degree in Engineering (Mechanical, Chemical, Biomedical, Industrial, or related field of engineering).
  • Typically requires 2-5 years of medical device or related engineering experience (1-3 years with Master's in Engineering).
  • Familiarity with Computer-Aided Design (CAD) preferred.
  • Green Belt in 5S/Lean Manufacturing preferred.
Other Factors of Job Performance:
  • Ability to follow, execute, convey moderately complex instructions to make engineering updates.
  • Knowledge of ANSI drawing.
  • Knowledge of ISO and FDA standards.
  • Demonstrates the ability to manage multiple tasks.
  • 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 high-quality work.
  • Is considered an emerging subject matter expert and resource for junior-level employees.
  • Demonstrates good interpersonal skills in a team environment.

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