Job Opportunity:
* We are seeking a seasoned Medical Devices Innovation Leader to spearhead the design, development, and testing of groundbreaking medical devices that have the potential to transform patient care and healthcare practices.
* The successful candidate will play a pivotal role in driving innovation, fostering collaboration across functional teams, and ensuring that devices meet user needs and industry standards.
Key Responsibilities:
* Develop and execute research strategies to drive the creation of innovative medical devices, taking into account usability, safety, and regulatory requirements.
* Collaborate with cross-functional teams including product managers, engineers, and clinicians to inform design decisions and ensure compliance with industry standards.
* Conduct feasibility studies, create prototypes, and perform testing and validation of designs to guarantee functionality and compliance.
* Stay abreast of emerging technologies, industry trends, and regulatory changes to maintain a competitive edge and inform strategic design decisions.
* Lead and mentor junior engineering staff, promoting a culture of innovation and excellence.
Qualifications and Skills:
* Bachelor's degree in Engineering, Mechanical Engineering, Biomedical Engineering, or related field.
* Master's degree preferred.
* Proven experience (5+ years) in medical device innovation, research, and development, 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.