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sr. software Quality ENGINEER

Position Summary

Leadership and hands-on position with focus on Software (SW) Quality for the embedded medical device software .  Provide oversight of software quality activities at contract design firm(s) for developing medical device software.

 

Individual

We are looking for a hands-on and enthusiastic individual with strong attention to detail and organizational skills with respect to medical device software quality engineering and assurance for medical device software. They must have excellent technical writing and review skills. They must be able to work very efficiently and communicate effectively via video conferencing and phone calls in Quality, Program Management, Engineering, Technology areas, both within the Chrono team and with external vendors. 

 

Main Responsibilities

  • Lead the Software Quality Engineering activities for embedded medical device software

  • Responsible for software design verification: planning, protocol development, requirements traceability, test execution, and reporting

  • Participate in the development and review of software design inputs

  • Collaborate with QE staff to ensure SW quality activities and deliverables are traceable to, and consistent with, other product documentation: such as risk analyses & controls, system requirements, hardware design verification, etc.

  • Quality representative on Mobile Application and Back End development teams

  • Provide quality oversight of contract design firms’ work on medical device software modules incorporated in the Mobile Application.  Quality approver of contract design firms’ software deliverables

  • Provide quality input and review of software design documents such as development plans, requirements, architecture, design descriptions/specifications, configuration management documents, etc.

  • Provide quality input and review of software-related QMS document such as SOPs and WIs.

  • Active participant in software design and code reviews, and software risk analysis

  • Active participant in software defect triage and resolution

 

Job Requirements

Education:

  • B.S. degree in Engineering or equivalent

Experience:

  • 5+ years in Software Quality Engineering in the medical device or drug/device combination product industry

  • Extensive knowledge of IEC 62304 and FDA guidances for software development. Working knowledge of ISO 13485, 21 CFR 820.30 Design Controls, ISO 14971, and cybersecurity standards and guidance

  • Working in a start-up environment developing processes for unique first generation products

Expertise:

  • Software quality: software lifecycle management, software verification and validation, tool validation, risk management, defect tracking and resolution

Travel Requirements:  

  • Ability to travel about 5-10% of the time, both domestic and international

 

APPLICATION FORM

Interested in the Senior Software Quality Engineer role? Please submit the following application form.

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