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Engineer III

Katalyst Healthcares and Life Sciences

Roles& Responsibilities:
  • The Combination and Medical Device Products Consumable Device US team is expanding its support for on-market devices.
  • This role will be responsible for on-market change execution, product lifecycle management, and manufacturing support specific to the product design.
  • Proficiency with medical device/pharmaceutical DHF traceability is required.
  • Proficiency with test execution, deviation reporting and management, data review, and report writing is required.
  • Experience with medical device EU and/or FDA regulations is required.
  • In addition to product support, you will also be responsible for standardizing and simplifying activities within the team to enable more efficient development and marketed product support.
Education & Experience:
  • Bachelor of Science degree with 3+ years of experience in medical device or pharmaceutical development roles.
  • Graduate degree in a technical or scientific field. Prior experience in consumable medical device/pharmaceutical development.
  • Medical device/pharmaceutical development, office, and laboratory settings.
  • Design History File product lifecycle management experience
  • Engineering degree in bioengineering, chemical engineering, or mechanical engineering
  • On-market supplier changes.
  • Knowledge of applicable global regulatory requirements and industry standards (MDR requirements, ISO 13485, ISO 14971, ISO 10993, etc.)
  • Exceptional written and verbal communication skills, and the ability to clearly articulate development challenges and implementation strategies to stakeholders across a broad range of functional groups at all levels of the organization, including external vendors.
Vacancy posted 2 days ago
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