Principal V&V Engineer - Medical Devie, V&V, C/C++, ISO, Matlab

Our client is a Medical Device company located in Irvine CA. They are urgently seeing a Sr./Principal V&V Software Engineer with exposure to C/C++, Embedded, RTOS, and Device control experience.

This engineer will be responsible for the design and development of products for ophthalmology surgical devices.

This position will be a Hybrid onsite opportunity. 

Key Responsibilities

• Provide system domain expertise to serve as the main integrator between the hardware and software functions.
• Proactively collaborate with global teams
• Work across functions and team boundaries to define, design, and implement the next generation of products.
• Create and iterate user needs, risk management, and product requirements while identifying plans for verification and validation
• Identify and mitigate project risks
• Interface with internal and external suppliers, manufacturers, and customers
• Work collaboratively with project teams and engineering skillsets through all stages of development
• Ensure regulatory, statutory, and, legislative compliance
  

Qualification

Required Knowledge, Skills And Abilities

• Comprehensive knowledge of medical device specialization with strong understanding of several engineering disciplines
• Demonstrated ability to lead with and without functional direct-line authority, effectively engaging key Stakeholders
• Effectively utilize problem solving skills and techniques to identify potential issues, assess their impact, and develop and implement mitigation and resolution plans and activities
• Full understanding of Design Control
• Experience with creation and full traceability across user needs, risk management, product requirements, and V&V
• Knowledge of ISO, regulatory and legislative standards applicable to the development of medical devices
• Excellent interpersonal and communication skills with all levels of associates, management, and external partners
• Experience with MATLAB Simulink, C/ C++, QT, QML, Linux
• Familiar with ARM and Sharc DSP microprocessors
  

Minimum Required Education And Experience

• Bachelor’s Degree or equivalent years of directly related experience (or Assoc. +14yrs; M.S. +7yrs; PhD +6yr)
• 7 years relevant experience in the medical device industry
• Fluent English
  

Physical Requirements

• Expected travel is 20%

THE OFFER 

• 150-170k Base salary
• Potential Bonus of 5-10%
• Full Medical, Dental and vision 

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