
Senior Medical Device Development Lead
22 hours ago
Job Description:
We are seeking a highly skilled and experienced Research Engineer to lead the design, development, and testing of innovative medical devices. The successful candidate will play a key role in shaping the future of healthcare through cutting-edge technology.
Responsibilities:
- Lead research projects, taking into consideration usability, safety, and regulatory requirements.
- Collaborate with cross-functional teams 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.
- 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.
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