Design Quality Engineer

Medtronic

Company Type
Industry
Experience
Workhours

In this position you will be responsible to ensure that the design control requirements for advanced medical devices are fulfilled. as part of PDP and CDP projects team, manages the risk management activities and documentation from the early stages of the development process and throughout the product life cycle.

1.       Reviews and approves product Verification and Validation documentation

·         Works with project teams in R&D (both new product development and Sustaining) reviewing and approving product documentation

·         manages the Risk management file throughout the product life cycle,

·         Reviews and approves design documents and processes in accordance with Design Controls standards and company's policies.

2.       Tracks and understands product Standards in order to guide others on their correct implementation.

3.       Implementation of statistical tools usage in R&D, e.g. Cpk, MSA, DOE.

Education:

  • BSc Engineering degree or higher

  • 6 sigma Certificate is an advantage

 

Experience:

·         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, IEC62304 and the Medical Device Directive

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

·         Reliability analysis and test methods

 

Preferred Skills/Qualifications:

·         Computer Skills: MS Office applications, prior experience with document management platforms (preferably Agile), miniTab experience is an advantage

·         Languages: Excellent command of English and Hebrew both oral and written

·         Excellent communication and interaction skills

 

 

Other Skills:

  • Thorough understanding of medical device quality system regulations

  • Proved experience with risk management processes

  • Familiar with software and electrical medical devices related standards

  • Demonstrated scientific analysis abilities

  • Meticulous attention to detail

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Confirmed 15 days ago. Posted 30+ days ago.

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