Job 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.