QA Engineer

Job Title: QA Engineer
Location: Valencia, CA
Duration: 4+ months

Required Qualifications:
BS degree in Computer Science or Software/Electrical Engineering
Minimum of 5 years of Software testing in commercial products.
Working knowledge of testing process and methodologies.
Manual testing experience in a regulated environment.
Understanding of Software Development Life Cycle Processes per IEC 62304
Some experience working on CAPA.
Some experience in Programming Languages such as C#, C++, Swift, Node.js, Java/JavaScript, Cloud, Windows, iOS, Android, Python, LabView.
Must be detail oriented and have a passion to "Build Quality In" the products.
Must possess excellent organizational, clear verbal and written communication skills.

Preferred Qualifications:
MS degree in Computer Science or Software/Electrical Engineering.
Experience working in the medical device industry or other highly regulated environment.
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).

Responsibilities 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 Boston Scientific 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 Boston Scientific 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.
Actively working on Software related CAPA.
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.

The job may entail sitting as well as working at a computer for extended periods of time. Candidates should be able to effectively communicate by telephone, email, and face to face.