Description:
We are seeking a dynamic and experienced Senior Research and Development Engineer with a focus on medical devices to join our team. The successful candidate will play a key role in the design, development, and testing of innovative medical devices that have the potential to improve patient outcomes and enhance healthcare practices.
Responsibilities
- Lead the research, design, and development of new medical devices, taking into consideration usability, safety, and regulatory requirements.
- Collaborate with cross-functional teams including product managers, engineers, and clinicians to ensure that devices meet user needs and industry standards.
- Conduct feasibility studies, create prototypes, and perform testing and validation of designs to ensure functionality and compliance.
- Stay abreast of industry trends, emerging technologies, and regulatory changes to inform design decisions and maintain a competitive edge.
- Mentor and provide technical guidance to junior engineering staff, fostering a culture of innovation and excellence.
Qualifications
- Bachelor's degree in Engineering, Mechanical Engineering, Biomedical Engineering, or related field. Master's degree preferred.
- Proven experience (5+ years) in the research and development of medical devices with a track record of successful project delivery.
- In-depth knowledge of medical device regulations (ISO 13485, FDA, CE Marking) and quality management systems.
- Proficiency in CAD software (e.g. SolidWorks), finite element analysis, and rapid prototyping methods.
- Strong problem-solving skills, ability to multitask, and excellent communication and collaboration abilities.