About Us:

Cue Health (Nasdaq: HLTH) is a mission-driven healthcare technology company that puts consumers in control of their health information and places diagnostic information at the center of care. Cue Health enables people to manage their health through real-time, actionable, and connected health information, offering individuals and their healthcare providers easy access to lab-quality diagnostics anywhere, anytime, in a device that fits in the palm of the hand. Cue Health’s first-of-its-kind COVID-19 test was the first FDA-authorized molecular diagnostic test for at-home and over-the-counter use without physician supervision. Outside the United States, Cue Health has received the CE mark in the European Union, Interim Order authorization from Health Canada, and regulatory approval from India’s Central Drugs Standard Control Organisation. Cue Health was founded in 2010 and is headquartered in San Diego. For more information, please visit www.cuehealth.com.

Cue Health Inc. is seeking to hire a full-time Staff Software Quality Engineer who will bring expertise in software quality & product validation engineering to the Quality Department of Cue Health. Under limited supervision of the Manager, Software Quality, the Staff Software Quality Engineer will assist with ensuring compliance to design control requirements, Validation and Verification activities and maintenance of validated state of software development environment for the development and validation of software in Cue Health’s in-vitro diagnostic medical device and other non-product software. This Staff Software Quality Engineer will work closely with the software development, product development, manufacturing, automation and process validation and other compliance teams to develop and implement high quality software validation strategies. This position requires knowledge of software & product verification and validation principles, Software development life cycle, SW maintenance and change management and utilization of Manufacturing SW tools and systems in manufacturing environment along with their application to Medical device/IVD standard requirements.

Responsibilities:

• Creation of functional requirements/ user requirements, trace matrices, risk management documents, validation reports and protocols

• Review, approve and execute/document test scripts, provide reports for validation of GXP impacting software systems, tools and enterprise level databases as well as product and development type Software applications (Jira, Github, Circle CI, other software development tools), and ensure their maintenance in validated state

• Write and execute validation plans & protocols as well as perform and document statistical analysis related to verification and validations.

• Coordinate with end users and process owners to lead development of validation strategy for projects, systems, and processes. These projects may span sustaining manufacturing and laboratories, the introduction of new enterprise level systems and solutions as well as processes and/or associated improvements

• Review and approve validation protocols and reports provided by internal teams or third-party suppliers (consultants, equipment / instrument manufacturers, etc.)

• Collaborate with the software validation teams in the creation and maintenance of software design history files (software development plan, software verification and validation plan, software requirements, software architecture and design specifications, test protocols and reports, and traceability matrices). Support of these documents includes participating in document reviews, providing feedback to ensure compliance, and approving documents

• Participate in development and maintenance of risk management process for software in Cue’s products, including hazards analysis, risk management plan, risk management report, and risk assessment of open software anomalies

• Ensure documents conform to internal SOPs and external standards and best practices

• Ensure Cue Health’s software development compliance to FDA 21 CFR 820.30 (design control), IEC 62304 (software development life cycle), ISO 14971 (risk management)

• Draft product SW related SOPs and guidance documents to ensure compliance with IEC 63204 and in particular management of SW anomalies, problem resolution process and SW maintenance activities.

• Support improvement in software quality through software quality assurance metrics and analytical tools

• Support internal SOPs on quality tasks (CAPA, complaints, etc.) related to software products.

• Learn and understand the applicable technologies and engage in technical discussions. Act as a subject matter expert for validation discussions

• Provide consultation to other departments performing SW V&V and change management activities.

• Leads large scale cross functional projects as assigned and deliver training materials.

• Other duties as assigned

Requirements:

• Bachelor’s degree in Computer Science, Computer Engineering, or Software Engineering or life science with Software background or equivalent

• 8+ years of relevant experience, such as in product and process software development, software quality assurance, or software and manufacturing process validation in a regulated industry

• Advanced understanding of software and process development as well as validation quality principles and practices in a regulated industry

• Advanced knowledge of software development tools - code repository, version control, compiler, builder, IDE, continuous integration, static and dynamic code analysis tools, etc.

• Knowledge of FDA guidance for medical device software validation and software lifecycle management.

• Understanding of ISO 13485, ISO 14971 and IEC 62304 principles

• Independent, self-starter with exceptional communication (written and verbal) skills, detail oriented, organized, and able to prioritize and balance multiple projects in a fast-paced environment.

• Ability to work both independently and in a team environment.

• Strong background utilizing Microsoft Office, including Microsoft Word, Excel, PowerPoint, etc., to perform critical job functions, trending, reporting metrics, etc.

• Ability to work extended hours as required

Environment and Physical Activities/Requirements:

• You will work in an indoor remote environment for which no adverse conditions are expected. This position requires the following physical activities and/or requirements:

  • Remaining in a stationary or sedentary position, often standing or sitting for prolonged periods of time.

  • Repeating motions, such as keyboarding, that may include the wrists, hands, and/or fingers.

  • Communicating with others to exchange information.

Your contribution will set the pace and have an impact in the technology, health, and diagnostic industry. Your work and ideas will be valued and respected, and we hope you will find enjoyment working with a collaborative team on an innovative device. We offer upgraded computer equipment, and a competitive salary.

Cue Health Inc. is an equal opportunity employer, consistent with applicable laws. Individuals seeking employment are considered without regards to race, color, religion (including religious accommodations), creed, sex (including pregnancy, childbirth and related medical conditions), gender (including gender identity and expression), sexual orientation, marital status, national origin (including language use restrictions), ancestry, mental and/or physical disability, medical condition (cancer, genetic information and characteristics, requests for medical and family care leave), age, military or veteran status, and any other classification protected by applicable federal, state, and local laws.