Senior R&D Engineer

23 hours ago


Burlington, Massachusetts, United States BioTalent Full time
Job Summary

Our client, a leading startup organization, is seeking a highly skilled Senior R&D Engineer to lead the development of new medical devices. The ideal candidate will have a strong background in mechanical, chemical, or biomedical engineering and experience in medical device development.

Key Responsibilities:

  • Develop and process new materials for medical devices
  • Manage design control activities and guide projects from concept to 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

Requirements:

  • 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


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