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.
