Staff Software Quality Engineer

Job Description
The Staff Software Quality Engineer is responsible for leading teams through the product and business software quality system. The incumbent will have insight into process implementation and advises the project team on how to optimally execute software processes and standards to meet the needs of the project.

•Working with software project teams to ensure regulations and compliance to ensure successful submissions and audits
•Lead software project teams to achieve the most efficient compliant process for product software development to reduce project costs.
•Continually provides feedback to refine the software development process to maximize effectiveness.

The individual will act as the leading representative of the Diabetes Care Team. Support medical device and mobile/desktop application software for new product development projects. Serve as Quality Assurance representative on project teams related to the development of non- product software applications. Interface with supplier and customer Quality Assurance personnel on software development projects to coordinate regulatory and development processes. •Participate on Software Review and Milestone committees and NPD Technical Review boards as requested. Prepare supplier software evaluation reports, gap analyses, and risk management plans to ensure software suppliers plan and deliver appropriate software and documentation.

Qualifications
Bachelor's degree in Computer Science, Software Engineering, Computer Engineering, or related field.
Minimum 5 years of experience of technical software experience, which includes design, coding, testing.
Experience in contributing to process improvement and expert-level knowledge of your current organization’s established software processes.
Possess excellent interpersonal skills and able to work effectively with a diverse group of people and senior executives.
Deep level of understanding and experience within medical device software development including, but not limited to FDA PMA and 510k submissions, EU IVD , and Technical Files.
Excellent communication and writing skills.
Strong negotiation skills
Able to effectively produce change.

Highly Preferred Qualifications:
•CSQE
•Experience developing systems that consist of medical devices which wirelessly communicate with mobile (iOS, Android) or cloud-based applications.
•Experience with SharePoint, DOORS, MKS.