Principal Research & Development Engineer

The Role: Our client, an established and scaling startup organization, is looking for a Sr. R&D Engineer their growing team, to lead the R&D efforts in bringing new life saving products to market. Responsibilities: Participate in developing and processing new materials for medical devices Manage design control activities, guiding projects from concept through testing and into commercialization. Fabricate and test prototype devices and communicate results with project teams. Plan, design, and execute studies using statistical and manufacturing approaches to analyze data and products. Generate clear reports from data and document all testing and results. Apply engineering knowledge to solve problems and suggest improvements. Work effectively in a project-focused team and collaborate with Marketing, Operations, Quality, and Regulatory Affairs during product development. Ensure all work follows good Documentation Practices (cGDP) and Medical Device regulations. Maintain compliance with SOPs for product development and equipment use. Conduct design verification, define product performance, and establish test protocols. Provide regular updates to internal teams. May supervise engineers, technicians, or co-ops and interact with outside contractors. Must Haves: BS in Mechanical, Chemical, Plastic/Materials, Biomedical Engineering. 7+ years in a medical device company. Plastics or Catheter experience. Strong understanding of quality systems and risk management. Experience working in a cleanroom environment. Design skills related to medical devices. Experience with implantable medical device development under design control. Proficiency in CAD (SolidWorks). Experience in polymer/hydrogel formulation chemistry and product development.

Created: 2025-02-12