Lead the Quality Assurance and Quality Engineering activities throughout the Software Development Lifecycle for new product development initiatives. Must be familiar with IEC-62304 (Software Development Lifecycle standard for Medical Devices).
Ensure that the software development process is compliant with applicable standards, regulations and guidance documents for medical devices.
Interface with other Insulet departments (e.g. Sr. Management, Operations, and Information Technology, Engineering, New Business Development and Regulatory Affairs) as well as other external parties on issues related to product development and launched product support.
Effectively communicate software and design and development regulations, optimize the development process, and ensure ambiguities and conflicting requirements are resolved are critical to the success of the position.