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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:
The R&D Engineer I/II is responsible for supporting product design and process development activities with compliance to all quality and regulatory requirements. The position has a scientific focus that includes implementation of formulation development, proto-type fabrication and characterization, along with additional process evaluation and data generation through designed experiments. Process development in an R&D environment may be followed by qualification and technology transfer into manufacturing. The R&D Engineer I/II will work in a multidisciplinary team of researchers. This is a multi-faceted job in a highly collaborative environment across multiple functions that will require flexibility as well as an ability to learn about and develop new technologies and explore new techniques in pursuit of process robustness and innovation.
The R&D Engineer I/II is expected to be a subject matter expert on but not limited to: polymer, biomedical, chemical, material science or mechanical engineering. The R&D Engineer I/II will support creating documentation necessary for regulatory submissions, ongoing publication efforts, and communicating directly with the Director of Research on all other tasks.
This is a full-time, on-site position, located in Brooklyn, New York. This role is an independent contributor role (i.e. no direct reports).
- Exercise technical judgement in the design, execution and interpretation of experiments within the scope of project responsibilities and ensure the use of professional concepts to solve complex problems in creative and effective ways, in conformance with scientific methods and procedures.
- Process and analyze results, with the goal of interpreting data towards in-vitro replicability;
- Supports material/design/process changes through design control process, with well-documented research/analyses.
- Author protocols and reports including engineering studies and design verification/validation activities.
- Aid in the development and execution of testing methods to aid in exploratory research, product development, and quality control; conduct chemical and mechanical property evaluation tests to assess the desirability of process or formulation changes.
- Prepare samples as required for manufacturing, testing, or other evaluations and data analysis.
- Attend and participate in voice-of-customer (VOC) labs
- Interface with external vendors on design components; interface with customers, supplier and internal cross-functional team members to develop specification and coordinate prototype fabrication.
- Support new equipment/process implementation as well as participate in process and product transfers to manufacturing.
- Maintain a laboratory notebook and other technical documentation according to required GLP/GMP guidelines.
- Understand and prioritize process improvements, design experiments to make those improvements,, and execute these plans in the laboratory.
- Provide support to marketing and sales team, support introduction of new technologies with development of presentations, sales tools, formulations and application data.
- Provide other project product support as needed in order to support Cresilon's business objectives.
- Create and execute product/process enhancement, and new product/process development plans as assigned.
- 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 company leadership to evaluate existing research practices and contribute to a culture of ethical, high-quality research operations within the organization.
- BS in Chemical Engineering, Polymer Engineering, Material Science & Engineering or related engineering discipline. An advanced degree (MS or PhD) is preferred.
- Minimum 2 years of previous laboratory experience is required. Lab experience in an industry setting within cGMP regulated environments is highly preferred.
- Adept experimentalist with hands-on experience in process development of polymeric materials and their characterization in an R&D or manufacturing environment required. Mechanical / electrical knowledge – ability to troubleshoot processing equipment is preferred.
- Mathematically inclined with strong analytical and problem-solving skills with the ability to be observant and to think creatively. Demonstrated ability to design experiments and analyze data with the use of appropriate quality and statistical methodologies. Six sigma green belt or black belt certification preferred.
- Demonstrated ability to work independently as well as be a strong team contributor. Ability to effectively work within a team and cross functionally to expedite completion of critical project tasks.
- Requires understanding of product/process design and engineering. Experience should include process development/validation and/or transfer/verification, protocols, and trouble shooting skills.
- Ability to handle multiple project assignments of medium scope and complexity and able to prioritize and complete work with a sense of urgency in a timely manner.
- Ability to lead directly and by influence, including strong problem solving, conflict resolution, and analytical skills.
- Working knowledge of Good Documentation Practices (GDP) and Good Manufacturing Practices (cGMP) requirements and/or work experience with medical device or pharmaceutical industries 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.
- Proficient in the use of Microsoft Excel, Microsoft Word, Microsoft PowerPoint is required.
- Requires excellent written and verbal communication and presentation skills.
- Legal authorization to work in the United States.
- Paid Vacation and Holidays
- Medical, Dental, and Vision Insurance
- Firm Paid Life and Short-Term Disability Coverage
- 401(k) Retirement Savings Plan
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