Senior R&D Engineer
23 hours ago
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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