R&D Engineer I
Cresilon, Inc is a medical device company based out of Brooklyn, NY that focuses on bringing new technologies to the animal health industry that aim to solve problems associated with wound healing. We have created a hemostatic device that can instantly stop traumatic bleeding.
Please refer to these associated links to learn more about Cresilon:
Description:The R&D Engineer is a subject matter expert on polymer science, chemical engineering, biomedical engineering and material engineering. The R&D Engineer is responsible for supporting product design, contributing to publication efforts, and communicating directly with management on all other tasks.
- Aid in the development of novel assays and testing methods to aid in exploratory research, product development, and quality control;
- Process and analyze results, with the goal of interpreting data towards defining product specifications and manufacturability;
- Communicate with external vendors on design components;
- Assist in design of experiments for process development;
- Maintain active dialogue with Regulatory Affairs as subject matter expert on all product design elements/documentation pertaining to Research towards FDA/regulated authority submissions;
- Work with Director of Research and other company leadership to evaluate existing Research practices and contribute to a culture of ethical, high-quality Research operations within the organization.
- BS or MS in Polymer, Chemical, Biomedical, Mechanical Engineering or related scientific discipline.
- 1 to 5 years of laboratory experience with cGMP regulated environments preferred.
- 1 to 5 years of medical device experience preferred.
- Working knowledge or project experience in general fluid dynamics or polymer-based fluid dynamics preferred.
- Working knowledge of ISO 9001, ISO 13485:2003 and ISO 14971:2007 preferred.
- Working knowledge of FDA requirements as per 21 CFR 820 preferred.
- Working knowledge of Good Documentation Practices (GDP) and Good Manufacturing Practices (cGMP) preferred.
- Experience should include method development/validation and/or transfer/verification, protocols, and trouble shooting skills.
- Requires understanding of product design, and process engineering.
- Proficient in the use of Microsoft Excel, Microsoft Word, and Minitab.
- Paid Vacation and Holidays, including a minimum of 25 vacation days
- Medical, Dental, and Vision Insurance
- Firm Paid Life and Short-Term Disability Coverage
- 401(k) Retirement Savings Plan
- Stock Options