Risk and System Engineer

LTS is a leading pharmaceutical technology company that develops and manufactures innovative drug delivery systems for the pharmaceutical industry.

LTS´ commercial offering encompasses more than 20 marketed products.

LTS operates today from 5 sites: Netanya, Israel, Adrenarche, Germany, West Caldwell, NJ, USA, St. Paul, MN, USA, and Shanghai, China.

We are looking for an excellent System Engineer to join our team in Israel.

The position is hybrid - 4 days a week from the office, and 1 day from home.

Job Description:

Demonstrating leadership and 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.
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.
Responsible for leading risk management activity, applying structured tools (FMECA, PFMEA, etc.) to drive mitigation of risks through product design.
Integral in all stages of new product development from requirements management through manufacturing transfer
Prepare (write/review) all system engineering related documentation for FDA approval.
Work closely with Product management and PMO.

Direct Manager: Director of system department

Job Requirements:

Education: Bachelor’s degree in Bio-Medical Engineering, or other related engineering discipline
Job skills:
2-5 years of work experience as a Technical Eng or System Eng. in medical devices
Previous experience in Risk Management a plus
Problem-solving and troubleshooting skills
Successful track record in leading cross-functional technical challenges
Experience in a global company – advantage
Computer skills: Full control of all MS-Office applications
Language skills: Fluent English – written and spoken
Personality: Self-driven, Can-Do attitude and great team player