Quality Engineer
- Employer
- Katalyst Healthcares & Life Sciences
- Location
- New York City, NY
- Closing date
- Oct 24, 2022
View more
- Sector
- Science, Physical Sciences and Engineering
- Organization Type
- Corporate
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Job Description
Roles and Responsibilities:
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.
- 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.
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