Principal Research & Development Engineer
BioTalent
Job ID: li-4142285638
Location: Burlington, MA
Description:
**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.
Remote: False
Min Salary: 0
Max Salary: 0
Salary Frequency: yearly
Posted Date:
URL: https://www.linkedin.com/jobs/view/4142285638
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