Sr. Software Design Quality Assurance Engineer
San Diego, CA

Job Description

Position Summary

This position is responsible for leading Quality Assurance and Quality Engineering activities throughout the Software Development Lifecycle for new product development initiatives and for automated data processing systems used as part of the quality system. This includes ensuring that the software development process is compliant with applicable standards, regulations and guidance documents for medical devices and GxP computerized systems. This role will 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, launched product support, and software used for automation of the quality system. The ability to 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.

Responsibilities

* ASQ, CSQE or other software quality certificates are beneficial.
* BS degree, in an engineering/scientific/computer systems/ or quality management curriculum or equivalent experience. Master's degree preferred.
* Experience with medical device software development.
* Experience with a risk-based approach to validate computerized systems, Commercial off the Shelf (COTS) software and SW Tools.
* Experience with software mobile applications, cloud based systems, and cybersecurity.
* A minimum of 10 years work experience in Software Quality Engineering within an FDA, ISO or other regulated environment and/or equivalent combination of education and experience.
* Experience in the development and implementation of effective Design Control Systems.
* Working knowledge of the Quality System Regulation (FDA 21 CFR Part 820) and ISO 13485 quality system standards.
* Working knowledge of IEC 62304, ISO 14971, IEC 62366, IEC 60601, and FDA guidance documents on software development, cybersecurity, and submission requirements for PMA and 510(k).
* Demonstrated experience organizing and maintaining large documentation sets.
* Experience with structured phase-gate product development processes.
* Familiarity with GAMP 5 guidance.
* Experience with software design V&V, computerized systems validations, and process validations.
* Familiarity with various software development tools (e.g. configuration management, issue/defect tracking, requirements analysis, etc.).
* Experience with software development lifecycles with emphasis on the software quality engineering aspects.

Education and Experience

* Effective verbal and written communication skills.
* Experience collaborating and communicate with individuals at multiple levels in an
* Ability to prioritize and manage critical project timelines in a fast paced environment. Must be able to handle multiple responsibilities concurrently.
* Strong analytical and problem solving skills.
* Able to work effectively in a high-stress, high-energy environment.
* Ability to manage people and projects in a fast moving environment.