Design Quality Engineer – Jerusalem

תיאור התפקיד

Careers that Change Lives

We’re a mission-driven leader in medical technology and solutions with a legacy of integrity and innovation. Join our team in Design Quality Assurance and help shape policies that change lives.

Be a part of a community of experts committed to ensuring quality, affordable healthcare worldwide.

Together, we can confront the challenges that will change the face of healthcare. Join us for a career that changes lives.

A Day in the Life

As a Design Quality Engineer, you will be taking an active part in the development of the company’s products, by ensuring that design control is properly maintained and executed, released products meet performance expectations, and changes to current product designs and service/repair of products in the field, follow the corresponding requirements set forth by local procedures, regulatory authorities and notified bodies

You will manage the risk management activities from the early stages of the development process and throughout the product lifecycle.

You will review and approve product Verification and Validation strategy

You will review and approve design documents and processes in accordance with Design Controls standards and company’s policies.

You will track product Standards to guide others on their correct implementation.

You will Implement statistical tools usage in R&D, e.g. Cpk, MSA, DOE.

דרישות התפקיד

Must Haves

BSc Engineering degree or higher

At least 2 years prior experience related to design quality in a medical device company

Working knowledge of the FDA Quality System Regulation 21CFR 820, 21CFR Part11, ISO13485, ISO14971 and the Medical Device Directive

Experience in risk evaluation techniques, e.g. FMEA, fault tree analysis

Reliability analysis and test methods

Working knowledge of  software and electrical medical devices related standards, IEC62304, IEC 60601, usability and human factors standards

Demonstrated scientific analysis abilities

 

Nice to Haves

6 sigma Certificate is an advantage

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