About the role
In our Research & Development Engineering Department, our Engineers focus on the ideation, design, prototyping, and manufacturing transfer of cutting-edge devices for use in medical procedures. Our R&D Engineers are directly involved with obtaining regulatory approval and patents as well as actively participating in clinical research studies.
Your responsibilities will include:
- Assist in the development of devices through prototyping, testing, and 3D modeling.
- Create and conduct verification and validation testing to validate design requirements and concepts.
- Prepare regulatory filings to various government bodies alongside our IP and Regulatory Affairs teams.
- Support clinical trials of devices and work with external suppliers and clinicians.
- Aid in the development and provision of technical documentation by preparing drawings, writing work instructions, and presenting technical insights.
- Monitor safety practices and ensure ISO 13485 and FDA compliance while collaborating with cross functional teams to meet product timelines.
- Other duties as required.
Required qualifications:
- Actively enrolled in a degree in Engineering or a recent graduate from an Engineering degree
- Strong interest in biomedical technology
- Motivated self-starter with a hands-on approach
- Ability to work independently and with a diverse group of Engineers and Clinicians
- Excellent communication skills, both written and oral
- Strong leadership and problem-solving skills
- Positive attitude and enthusiasm
Preferred qualifications:
- Six Sigma or LEAN knowledge
- Experience with SolidWorks and Minitab
- Experience in a highly regulated manufacturing environment
- Knowledge of ISO 13485