As part of your day to day you will :
· Own design changes and be responsible for the ECNs from end to end.
· Manage technical investigations of failures or low yield performance issues.
· Plan, Update and Reports on project progress
· Prepare and present technical reviews (TRR, DRs, CCB)
· Construction and management of product DMR including BOM, SOP’s, Mechanical & electrical specs.
· Manage EOL cases to minimize risk to production and optimize cost.
· 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.
· Collaborate and communicate with a vast network of global stakeholders.
Qualifications Must Haves
· BSc.in Mechanical Engineering
· Minimum of 5 years of relevant experience in Engineering & manufacturing environments
· Proven experience in multi-disciplinary products
· Fluent in Hebrew and English
· Experience or extensive knowledge of at least 2 related disciplines from the below:
1. Design experience of sub systems in a multidisciplinary machine.
2. Sustain engineering experience
3. NPI experience
4. Knowledge and experience in motion control
5. Process validation experience
Nice to have:
· 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
· Knowledge of quality systems (QMS)
· Experience in research and development of multidisciplinary systems.
· Excellent written and verbal communication skills in English
· Master’s degree (in a relevant field)
· Experience with design of surgical tools
· Solidworks, WCL expertise
· Quality related knowledge e.g. SPC, ANOVA, Gauge RnR, pfmea
