Primary Function of Position:
The Medical Device Engineer will lead the design and fabrication of instrumentation for prototypes intended for clinical translation. More particularly, he or she will support the global team of engineers with knowledge in the CE marking regulation and assist in providing expertise and guidance in the design workflow for clinical translation. He or she will also be responsible of articulating the link between the engineering team and clinicians by creating and registering protocols for ex-vivo and in-vivo testing for the prototypes as well as participating in the trials with the clinicians.
Roles and Responsibilities:
- Design sub-components of a prototype imaging system for compliance with applicable regulations for CE marking
- Implement a project workflow for the development of clinically compatible prototypes, including good practices and documentation procedures
- Stay informed regarding the most recent and up-to-date regulations for clinical translation in Europe (MDR & IECs in particular)
- Influence design ideas and ways to innovate at the interface of engineering and regulations
- Actively contribute to multidisciplinary translational and collaborative teamwork, play an active liaison role among engineers, researchers and clinicians
- Present the results of the work during internal meetings and international conferences
Required Knowledge, Skills, and Experience:
- Minimum a MSc in Biomedical Engineering (preferred), Electrical Engineering, Mechanical Engineering, Systems Design, Physics, or a related discipline. PhD would be a plus.
- Preferably 3 years minimum of experience in applied research or industry
- Strong knowledge and experience in all aspects of instrumentation
- Eager to self-improve, gain knowledge and develop skills
- Good level of English, spoken and written
- Self-motivated and autonomous
Intuitive is an Equal Employment Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws.
We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.
Shift : Day
Travel : 10% of the time