Demonstrating leadership and advanced technical knowledge to oversight teams of R&D engineers (Mechanical, HW and SW) in development of the company line of On Body Injectors (OBI) from concept to release.
Translating customer User Needs (UN) into actionable user and system technical requirements (MeRS, HRS, SRS).
Lead technical decision-making in the project while collaborating with cross-functional peers within the R&D.
Support and verify system integration, system testing, and validation and verification covers design inputs and outputs correctly.
Maintain strong communication across departments and divisions to ensure effective development process, requirements gathering, and operational planning in the development.
Plan and oversee tasks breakdown and execution within the R&D teams and designated projects in desired quality and on time.
Prepare (write/review) all system engineering related ation for FDA approval.
Work closely with Product management and PMO.
Take part in technical meetings with international partners.
Education: Mechanical/Biomedical/Electrical Engineering
3-5 years of work experience as a Technical TL or System Eng. in medical devices
3-5 years of hands-on technical/development experience
Problem-solving and troubleshooting skills
Demonstrated technical leadership and ownership
Successful track record in leading cross-functional technical challenges
Experience in a global company – advantage
Full control of all MS-Office applications
Background in programming – advantage
Language skills: Fluent English – written and spoken