Research and Development Medical Device Engineer at Cresilon, Inc.

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. They have created a hemostatic device that can instantly stop traumatic bleeding. The Medical Device Engineer is responsible for leading design and development activities of new products and improving existing products with compliance to all quality and regulatory requirements. S/he will be responsible for authoring technical documents for the development of medical devices and combination products according to relevant Design Control regulations and standards. The position will also be responsible for providing project specific support, including technical analysis and review of supplier documentation as required. Responsibilities: - Create and lead experimentation for exploratory and/or product development research with focus on polymeric materials devices and their use. - Define new product functional requirements (design inputs/user needs) and evaluate the design's overall effectiveness, cost, reliability, and safety. - Lead cross-functional teams to develop new products, address design issues, and maintain existing designs. - Apply strong problem-solving skills to find solutions to complex problems. - Work independently to plan and schedule own activities necessary to meet project timelines. - Work cooperatively with, quality, manufacturing, regulatory, clinical, and marketing to ensure project success. - Lead the creation of design history file documentation through the new product development process. - Develop new implant and instrument designs utilizing Solidworks and modeling/detail design specifications. - Generate technical protocols/reports to support device safety and efficacy. - Invent/create concepts and designs and submit invention disclosures. - Ensuring that all design activities adhere to FDA Quality System Regulations and ISO 13485 design control and risk management requirements. - Lead material/design/process changes through design control process, with well-documented research/analyses. - Author protocols and reports including development studies and design verification/validation activities. - Develop and execute of test 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. - Exercise technical judgment in the design, execution and interpretation of experiments within the scope of project responsibilities and ensure the use professional concepts to solve complex problems in creative and effective ways, in conformance with scientific methods and procedures. - Prepare samples as required for testing, or other evaluations and data analysis, including in voice-of-customer (VOC) labs. - Interface with customers, suppliers, and internal cross-functional team members to develop specifications and coordinate prototype fabrication. - Maintain a laboratory notebook and other technical documentation according to required GLP/GMP guidelines. - Maintain active dialogue with Regulatory Affairs as subject matter expert on all product design elements/documentation pertaining to research towards FDA/regulated authority submissions, - Provide support to marketing and sales team, support introduction of new technologies with development of presentations, sales tools, formulations and applications data - Communicate results to the scientific community via published papers. - Present research at academic/industry symposia as an external representative of the company. - Manage part-time staff as a research leader and mentor for ongoing research projects. - Work with company leadership to evaluate existing research practices and contribute to a culture of ethical, high-quality research operations within the organization. - Provide other project or product support as needed in order to support Cresilon’s business objective. Responsibilities may include other duties as assigned and as required

Research and Development Medical Device Engineer

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About Cresilon, Inc.:

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www.cresilon.com

Admin access needed