
Senior Medical Device Development Specialist
24 hours ago
We are seeking a highly skilled professional to contribute to the design, development, and testing of innovative medical devices.
Job 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.
- Maintain up-to-date knowledge of industry trends, emerging technologies, and regulatory changes to inform design decisions and maintain a competitive edge.
- Provide technical guidance and mentor junior engineering staff, fostering a culture of innovation and excellence.
- 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.
The ideal candidate will have a strong passion for innovation, a keen eye for detail, and excellent collaboration skills.
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