commercialized product, Optune, is approved for the treatment of adult patients with glioblastoma (GBM) in the USA, Europe, and Israel.
has ongoing or completed clinical trials and is further expanding its efforts into several other solid tumor indications – non-small cell lung cancer, pancreatic cancer, and other types of solid cancers.
As part of an effort to extend engineering department, we are Looking for a Design Transfer & Sustain Engineering manager to manage the Design Transfer & Sustain engineering team as part of the Product Development group and will participate in the development of the companys project as well as maintain the companys existing products.
We are looking for a highly motivated and energetic professional Engineer for a full-time position as a Design Transfer & Sustain Eng manager.
The job holder will work together with Engineering, NPI, and Manufacturing teams as well as other cross functional teams to develop and support our expanding portfolio of engineering products related to our cancer treatment device from concept through manufacturing, taking into consideration quality, regulation cost-effectiveness, and manufacturing feasibility. A successful candidate will be a natural team player, able to swiftly prioritize and balance multiple programs, and have a background in Electrical STD. , Mechanical Knowledge, Safety, and Medical Device Requirements.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Lead Design transfer and sustain engineering activities.
Manage, Train, and develop the design team members of the Design Transfer & Sustain Group
Being the company source of knowledge on DFM and Sustain engineering, and providing technical advice, for all DT and Production activities.
A deep systemic understanding of company processes, configuration management, and the ability to propose comprehensive solutions for configuration processes and constraints in the PLM system.
Supervise, mentor, and lead the Configuration control team (Approach, timeline priorities)
Significant experience with transfer designs HW and Mech into manufacturing
Providing R&D teams with DFM and testability inputs to ease on the future transfer process
Maintaining and modifying the designs to ensure that the device is robust and designed for manufacturability.
Ensuring the team provides the data for a full production file (PCB, P CBA’s, assembly drawings and instructions, BOM)
Define budget and timeline for all team tasks
Liaising with suppliers and production subcontractors.
Undertaking relevant research, and working with external experts.
Hands-on Electrical/Mech design of products
Lead Electrical/Mechanical design reviews
Guide and support other team members
BSc in Electrical Engineering or Mechanical Engineering must
MSc in Electrical Engineering, Mechanical Engineering, or Industrial Engineering advantage.
Knowledge:
10 years of engineering experience
5 years leading Sustain Engineering in a regulated environment medical devices experience is an advantage
Significant experience working in Medical Device companies and knowledge of medical standards requirements- advantage
Previous experience with Agile PLM is an advantage
Shows strong Multi-discipline Knowledge of Electrical and mechanical MFR processes.
A proven experience at a Medical device company and vast experience with regulatory constraints.
Experience leading projects from design handover to manufacturing transfer.
Technical and analytical abilities.
Team player, working in a cross-cross-functional environ
