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Join a team that is changing millions of lives.
Transforming smiles. Transforming lives. Transforming an industry.
At Align Technology, we believe a great smile can transform a person’s life, so we create technology that gives people the confidence to take on whatever’s next. We revolutionized the orthodontic industry with the introduction of the Invisalign system, and we have never lost sight of that spirit of innovation. Our teams are constantly pushing the boundaries of what’s possible.
Ready to join us?
About this opportunity
Leading all the HW/system verification and validation activities required to release the system/product to production. Working with R&D departments (mechanics, embedded, electronics, SW, etc) to specify execute and report all the tests required, working with QA\RA for medical QMS compliance.
In this role, you will…
Lead the following teams and activities:
HW V&V team, for testing dental scanner system
Clinical validation team for validating new clinical features presented to the doctors
Continuous reliability team, leading all reliability and aging tests for the system
V&V contractors, for leading various short-term V&V activities.
Working with external labs (Carmel, SII, Aminolab) – performing regulatory & environmental tests
In this role, you’ll need …
Bachelor’s degree in Systems Engineering, Mechanical Engineering, Electrical Engineering, Biomedical Engineering or related field
Professional experience (more than 15 years) leading or supporting product Verification and Validation teams
Must come from multi-disciplinary companies, preferred medical.
Working knowledge of regulatory standards applicable to design of medical devices, including FDA QSR 21 CFR 820, ISO 13845, ISO 14971 and IEC 60601.
Proficiency with statistical techniques including familiarity with Gage R&R, Reliability, analysis of variance (ANOVA) and design of experiment (DOE) methodologies highly desired
Strong project management skills, knows how to build detailed plan
Technical - Capable of taking requirements to detailed spec, assist the team to define the detailed tests required
Experience working with Medical QA QMS, having design controls expertise
Experience solving problems, provides detailed insight and constructive criticism in complex situations, and foresees problems along with potential solutions
Experience as lead in the development of medical disposable devices
Leadership and team building skills, large scale manager also having (preferred) automation capabilities
Capable of creating relationships with external labs and companies
Experience with implementing tests through a structured, phase-gated product development process
Experience with design best practices, including design for reliability and testability, expertise in common risk management techniques
Sound like a good fit?
Great! Click the Apply link below to let us know you are interested. Not the right fit? Don’t worry, there are lots more opportunities. Please consider sharing this opportunity with others in your network.
Invisalign clear aligners, iTero Intraoral scanners, and OrthoCAD digital services that help dental professionals achieve the clinical results they expect and deliver effective, cutting-edge dental options to their patients.
Align היא חברה אמריקאית אשר יושבת בקליפורניה. החברה הגלובלית מונה למעלה מ-15 אלף עובדים ונסחרת בבורסת הנאסד"ק (ALGN) עם מחזור שנתי של 2.7 מיליארד דולר. כיום חטיבת מערכות הסריקה והשירותים הדיגיטליים של iTero מעסיקה למעלה מ-400 עובדים בישראל, והמחזור השנתי שלה ב-2019 נסק ל-400 מיליון דולר.