Quality Engineer

Katalyst Healthcares & Life Sciences
New York City, NY
Closing date
Oct 9, 2022

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Job Description
Roles and Responsibilities:
  • Plan, outline, and execute the product development process bringing a product through to FDA clearance.
  • Understand and execute design control requirements and complete necessary documentation supporting these requirements.
  • Develop experiments in line with GLP and GMP requirements and conduct testing to support research.
  • Collaborate with external clients and organizations to facilitate the product development process.
  • Assist with the R&D process and prototype development as needed.
  • Partner with clients to create realistic designs that can go through the manufacturing process.
  • Continually learn and grow in the industry, train others when needed, and actively contribute to the overall success of the company.
Education and Experience:
  • Experience overseeing the product development process in a medical device company working preferably with soft tissue or collagen.
  • Experience with Class II or higher medical device is preferred but not required.
  • 2 years+ of industry experience in bringing medical device products to FDA clearance. This could be a challenging role for different levels based on the background the ideal candidate brings to the table.
  • True team player with a positive mentally, ability to work in a supportive group environment, communicate ideas and information clearly and a general flexibility.
  • Knowledge of design controls related to medical devices including ISO 10993 and ISO 22442.
  • Understanding of the validation protocols needed for an assay in product development.
  • Experience with collagen-based materials, protein-based materials or hydrogels is preferred.
  • Rheology experience is preferred.
  • Solidworks or similar is preferred.
  • A passion for learning and professional growth are required and a sense of humor is highly preferred.
: 22-01942 : New York, NY:

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