Apex Systems is currently seeking a Software Quality Assurance Engineer for one of our top Medical Device clients in Valencia, CA.

Please see below for details about this exciting growth opportunity, and email Lisa at [email protected] asap to learn more!

Job Description
Hybrid
This position is anticipated to be up to 12 months in duration.

About the role:
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.

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

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 the clientsNeuromodulation 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 our clients 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)

EEO Employer

Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at [email protected] or 844-463-6178 .

Apex Systems is a world-class IT services company that serves thousands of clients across the globe. When you join Apex, you become part of a team that values innovation, collaboration, and continuous learning. We offer quality career resources, training, certifications, development opportunities, and a comprehensive benefits package. Our commitment to excellence is reflected in many awards, including ClearlyRated's Best of Staffing® in Talent Satisfaction in the United States and Great Place to Work® in the United Kingdom and Mexico.