Software Quality Engineer III

Job Description
Job Role: Software Quality Engineer III

Overview:

From development to commercialization, we partner with Pharmaceutical, Medical Device and Biotechnology clients to provide solutions to complex compliance issues. We collaborate with our partners by providing technical expertise in Quality, Regulatory Compliance and Manufacturing Science and Technology. Our business mission is to ensure our clients exceed their compliance goals while improving patient health and safety. Visit us at www.pharmavise.com

Our Fortune 500 client has an exciting opportunity for Software Quality Engineer III.

Job Summary:

The Software Quality Assurance Engineer III will serve as a Quality representative in the Neuromodulation Software/Firmware product development. The Software Quality Assurance Engineer III will provide Quality Engineering input throughout the product life cycle process. The Software Quality Assurance Engineer III will be actively participating in design activities of new product development and sustaining activities for commercialized product. The Software Quality Assurance Engineer III will be involved in the development, testing and validation of Software/Firmware products. In the Neuromodulation division, we continue to advance science in electronic implantable technologies that help patients manage debilitating chronic pain and neurological conditions such as movement disorders.

Responsibilities and Job Requirements:

This is a hybrid position based out of Valencia, CA with the expectation to be on-site 3 days a week.

Your responsibilities will include:
• Actively working within a team of Product Software Quality Assurance Engineers.
• Actively contributing to all aspects of Software/Firmware Quality Assurance activities in a highly regulated Active Implantable Medical Device environment.
• Ensures the quality of software systems, validate product software and firmware requirements, security requirements and compliances.
• Oversee design, development, and test of software related to all Client's Neuromodulation product lines during their entire development life cycle, from requirements gathering phase to the retirement phase.
• Creation and execution of Design Validation Plan, Protocols and Reports to perform System level testing of Neuromodulation products and report any issues discovered.
• Perform review of design, development, and testing of software and firmware used in Client's Neuromodulation product lines.
• Perform review and approval of documentation associated with user requirements, hazard analysis, security risk assessment, usability, functional and design specifications, design reviews, test protocols, requirements traceability, etc.
• Actively working to support Automated Test Equipment validation activities.
• Validation activities, which encompass reviews of User Needs Requirements, Design Requirements, Functional, Architectural, Module Design Details, Code and Design reviews, Unit tests, Integration tests, System level (black box), Structural (white box), Test Automation, Ad-Hoc/Exploratory test activities, Cybersecurity, Usability, and Risk Management, Design FMEAs, and Hazard Analysis.

Required qualifications:
• BS degree in Computer Science or Software/Electrical Engineering
• 5-8 years with BS degree, 3-6 years with MS degree, 0-3 years with PhD
• Minimum of 3 years of Software testing in commercial products
• Working knowledge of testing process and methodologies
• Manual testing and documentation experience in a regulated environment
• Understanding of Software Development Life Cycle Processes per IEC 62304
• Some experience in Programming Languages such as C#, C++, Swift, Node.js, Java/JavaScript, Cloud, Windows, iOS, Android, Python, LabView

Preferred qualifications:
• MS degree in Computer Science or Software/Electrical Engineering
• Must possess excellent organizational, clear verbal and written communication skills
• Must be team-oriented with people skills and positive can-do attitude in dealing with a large number of customers, and several competing tasks from various departments (R&D, Marketing, Manufacturing, Quality and Regulatory, Clinical, Project Management, etc.)
• Must be detail oriented and have a passion to "Build Quality In" the products
• Experience working in the medical device industry or other highly regulated environment
• Basic academic knowledge of principles of Neuromodulation
• Experience with CAPA, Complaint Handling and External Audit
• Experience/Understanding of Risk Management as per ISO 14971
• Understand Premarket Cybersecurity Guidance, Post Market Cybersecurity Guidance and 81001-5-1
• Understand Bluetooth technology
• Understand Mobile applications development
• Understand aspects of HIPAA and GDPR compliance practices
• ASQ Certified Quality Engineer (CQE) or ASQ Certified Software Quality Engineer (CSQE)

Other Details:

Schedule: 08:00:AM - 04:30:PM
Contract: 12 months
Hybrid Set Up at Valencia, CA