Senior Medical Device Research and Development Engineer

Responsibilities

• 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 and address design issues
• Develop new implant and instrument designs utilizing Solidworks
• Generate technical protocols and reports to support device safety and efficacy
• Ensure design activities adhere to FDA Quality System Regulations and ISO 13485
• Develop and execute test methods for exploratory research and quality control
• Maintain laboratory notebooks and technical documentation to GLP/GMP guidelines
• Support marketing and sales teams with technical presentations and application data
• Manage part-time staff as a research leader and mentor

Requirements

• BS in Chemical, Polymer, Biomedical, or Mechanical Engineering or related scientific discipline
• Minimum 5+ years of product development experience
• Minimum 4 years of hands-on R&D experience in a cGMP-regulated industry
• Experience in medical device product development and safety/efficacy characterization
• Experience gathering user needs and developing V&V plans
• Knowledge of anatomy and surgical procedures
• Proficiency in designing experiments and analyzing data with statistical methodologies
• Working knowledge of FDA 21 CFR 820, ISO 13485, and ISO 14971
• Working knowledge of GDP and cGMP
• Proficiency in Microsoft Excel, Word, and PowerPoint
• Legal authorization to work in the United States

Preferred Qualifications

• Advanced degree (MS or Ph.D.)
• Experience with Class II and Class III medical devices
• Experience with IDE and PMA submissions
• Six-Sigma green belt or black belt certification

About the Company

Cresilon is a Brooklyn-based biotechnology company that develops, manufactures, and markets hemostatic medical devices utilizing proprietary hydrogel technology to stop traumatic and surgical bleeds.