Demo

Principal Research & Development Engineer

BioTalent
Burlington, MA Full Time
POSTED ON 2/8/2025
AVAILABLE BEFORE 5/6/2025

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.
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