Senior Medical Device Research and Development Engineer

Company Overview

Cresilon® is a Brooklyn-based biotechnology company that develops, manufactures, and markets hemostatic medical devices utilizing the company's proprietary hydrogel technology. The plant‑based technology stops traumatic and surgical bleeds in seconds without prolonged manual pressure. The products target veterinary, human trauma, and human surgical applications.

The Senior Medical Device R&D Engineer leads design and development activities for new and existing products, ensuring compliance with all quality and regulatory requirements. Responsibilities include authoring technical documents for medical devices and combination products, providing project‑specific support, technical analysis, and review of supplier documentation. The role focuses on formulation development, product performance characterization, prototype design and fabrication, and data generation through designed experiments.

The Engineer is expected to demonstrate a bias toward action, hands‑on involvement, and a commitment to designing best‑in‑class products. This multi‑faceted role requires collaboration across researchers and functions, learning new technologies, and exploring innovative techniques.

• Create and lead experimentation for exploratory and product development research focusing on polymeric materials devices
• Define new product functional requirements and evaluate design 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
• Plan and schedule own activities to meet project timelines
• Cooperate 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 Solid Works and modeling/detail design specifications
• Generate technical protocols/reports to support device safety and efficacy
• Invent and submit invention disclosures
• Ensure compliance with FDA Quality System Regulations and ISO 13485 design control and risk management requirements; lead material/design/process changes
• Author protocols and reports including development studies and design verification/validation activities
• Develop and execute test methods for exploratory research, product development, and quality control; conduct chemical and mechanical property evaluation tests
• Exercise technical judgment in the design, execution, and interpretation of experiments, ensuring professional concepts solve complex problems
• Prepare samples for testing and data analysis, including voice‑of‑customer labs
• Interface with customers, suppliers, and internal cross‑functional team members to develop specifications and coordinate prototype fabrication
• Maintain laboratory notebook and technical documentation to GLP/GMP guidelines
• Maintain active dialogue with Regulatory Affairs on product design and documentation for FDA/regulated authority submissions
• Support marketing and sales teams by developing presentations, sales tools, formulations, and applications data
• Communicate results via published papers and presentations at academic/industry symposia
• Manage part‑time staff and mentor ongoing research projects
• Collaborate with leadership to evaluate research practices and promote ethical, high‑quality research operations
• Provide additional project or product support as needed to support Cresilon’s business objectives

• BS in Chemical Engineering, Polymer Engineering, Materials Science, Biomedical Engineering, Mechanical Engineering, or related discipline
• Minimum 5+ years of product development experience
• Minimum 4 years of hands‑on experience in new product research and development in a cGMP‑regulated industry (preferred in Medical Device field)
• Experimentalist with experience in product development of medical devices and safety/efficacy characterization in an R&D environment
• Experience gathering user needs, translating to technical inputs, and developing viable V&V plans
• Experience leading complex…