Senior Medical Device Research and Development Engineer

About the role

Cresilon® is a Brooklyn-based biotechnology company that develops, manufactures, and markets hemostatic medical devices utilizing the company's proprietary hydrogel technology. The company's plant-based technology has revolutionized the current standard by stopping traumatic and surgical bleeds in seconds without the need for extended manual pressure. The company's current and future product lines target veterinary, human trauma, and human surgical applications. Cresilon's mission is to save lives. Learn more about the company at www.cresilon.com.

Responsibilities

• Create and lead experimentation for exploratory and/or product development research focusing 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
• Ensure 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 a design control process, with well-documented research/analyses
• Author protocols and reports including development studies and design verification/validation activities
• Develop and execute 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 of 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 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
• Support the marketing and sales team, support the introduction of new technologies with the 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 objectives

Requirements

• BS in Chemical Engineering, Polymer Engineering, Material Science, Biomedical Engineering, Mechanical Engineering, or related scientific discipline
• A minimum of 5+ years of product development experience is required. A minimum of 4 years of hands-on experience in new product research and development in a cGMP-regulated industry is required (work experience in the Medical Device field is strongly preferred)
• Adept experimentalist with hands-on experience in product development of medical devices and their safety/efficacy characterization in an R&D environment
• Experience gathering user needs, translating them to technical inputs, and developing viable V&V (Design Verification and Validation) plans
• Experience leading complex product development initiatives from concept through product launch/release
• Good working knowledge of anatomy and surgical procedures is required
• Demonstrated ability to solve difficult technical problems and deliver practical solutions that meet the application requirements is required. This includes strong analytical, problem-solving, and decision-making skills with the ability to be observant and to think creatively
• Demonstrated ability to design experiments and analyze data with appropriate quality and statistical methodologies
• Demonstrated ability to work independently as well as effectively be a strong team contributor and work cross-functionally to expedite the completion of critical project tasks
• 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
• Requires strong leadership skills, excellent written and verbal communication and presentation skills
• Working knowledge of FDA requirements as per 21 CFR 820, ISO 9001, ISO 13485:2003, and ISO 14971:2007. Working knowledge of Good Documentation Practices (GDP), and Good Manufacturing Practices (cGMP)
• Good understanding of statistical tools and validation/verification techniques
• Proficiency in the use of Microsoft Excel, Microsoft Word, and Microsoft PowerPoint is required