For a hi-tech company developing medical devices, with offices in the north Sharon.
Analyze engineering processes (technical and managerial) in order to drive improvements and simplifications.
Own areas of expertise and be a professional authority company wide.
Own design changes and be responsible for the ECNs from end to end.
Manage technical investigations of failures or poor performance issues.
Prepare and present technical reviews (TRR, DRs, CCB)
Design, qualify, document and validate assembly & test fixtures/Jigs and tools, release to production and service.
Design (using Solidworks) changes to existing systems based on research of failures as well as design new solutions to solve technical issues and needs.
Evaluate plan and execute cost reduction projects.
Manage EOL cases to minimize risk to production and optimize cost.
Seek new manufacturing technologies to improve performance and cost.
Manage NPI programs to have successful transition to production.
Construction and management of product DMR including BOM, SOP's, Mechanical & electrical specs.
Collaborate and communicate with a vast network of global stakeholders.
Internal: R&D departments (System, VnV, Robotics), QA/RA, Operations and Product
External: Suppliers, Sub-Contractors.
BSc.in Mechanical Engineering
Minimum of 15 years of relevant experience in Engineering & manufacturing environments with at least 4 years of system development.
Proven experience in multi-disciplinary products
Fluent in Hebrew and English
Experience or extensive knowledge of at least 2 related disciplines from the below:
Design experience of sub systems in a multidisciplinary machine.
Quality related knowledge e.g. SPC, ANOVA, Gauge RnR
Sustain engineering experience
Knowledge and experience in motion control
Nice to have:
MSc in Engineering (relevant field)
Experience in Medical Device companies or other highly regulated industries
Understanding and knowledge of relevant regulations and standards FDA QSR, ISO 13485, ISO 14971, MDD-significant advantage
Proficient in MATLAB
Knowledge of quality systems (QMS)
Excellent written and verbal communication skills in English
Masters degree (in a relevant field)
Experience with design of surgical tools
Solidworks, WCL expertise
Biotech/medical, High Tech
Medium (50 - 150)