Principal Software Quality Engineer

MiniMed•San Diego, CA

9d•$109,000 - $185,000•Hybrid

About The Position

The Principal Software Quality Engineer works as part of the core new product development team to lead software quality activities for digital health solutions, including mobile applications (iOS/Android), web applications, and cloud-based data-driven solutions. The candidate must possess deep expertise in software development life cycle processes (Waterfall/Agile/DevOps) as applied within the regulated medical device industry. This is a Hybrid role based in Northridge, CA.

Requirements

Bachelor’s degree in engineering, Science, or Technical Field with 7+ years of relevant experience in Quality, Engineering, and/or Software Development OR Advanced Degree in Engineering, Science, or Technical Field with 5+ years of relevant experience in Quality, Engineering, and/or Software Development.
Must have working knowledge of medical device compliance standards including ISO 13485, IEC 62304, HIPAA, FDA QMSR, Security Standards, and Data Privacy regulations
Ability to author technical reports, business correspondence, and standard operating procedures

Nice To Haves

Experience in software design and development, verification, validation, and testing activities for mobile application development (and/or web applications and cloud infrastructure services (Amazon AWS/Microsoft Azure).
Experience executing in the SDLC environment leveraging ALM tools (e.g., PTC Integrity/Atlassian Suite/TFS), defect tracking tools (e.g., Jira/PTC)
Exposure to wireless communication protocols (e.g., Bluetooth).
Working knowledge of integrated digital health systems including consumer products such as Apple/Android products.
CQE or CSQE Certification preferred.

Responsibilities

Lead as a quality core team member responsible for driving quality into the design and development of digital health solutions including medical mobile device applications (iOS/Android), web applications, cloud technologies (AWS/IBM Watson), data reports, and AI/ML solutions; lead the collaborative quality strategy for projects in alignment with business goals for cross-functional teams including R&D, Med Safety, Regulatory, Marketing, and DevOps.
Leads quality oversight and evaluation of software systems activities across the software development lifecycle (Agile/Waterfall/DevOps) including requirements, design, development, documentation, integration, test, verification and validation; leads design reviews and reviews and approves design input/design output artifacts ensuring project and process control documentation comply with procedural requirements, applicable standards and regulations, with full requirement traceability maintained and documented.
Lead and conduct risk management activities including system risk analysis and software FMEAs; manages and triages software issues with the cross-functional teams.
Develops, modifies, applies, and maintains standards for software systems quality operating methods, processes, and procedures; develops overall operating criteria to ensure implementation of the software quality program according to project, process, and contract requirements and objectives.
Lead and drive CAPA (Corrective and Preventative Action) projects; lead quality improvement projects to include compliance standards for software quality operating methods, processes, and procedures.
Participate in both internal and external regulatory audits and inspections; and supports Quality Management System reviews of Standard Operating Procedures aligned with US and international standards.
Supports post-market team for FCAs or HRAs as needed.