Boston Scientific Software Quality Assurance Engineer II 

United States, California, Santa Clarita 

78133771

About the role:
The Software Quality Assurance Engineer II will serve as a Quality representative in the Neuromodulation Software/Firmware product development. The Software Quality Assurance Engineer II will provide Quality Engineering input throughout the product life cycle process. The Software Quality Assurance Engineer II will be actively participating in design activities of new product development and sustaining activities for commercialized product. The Software Quality Assurance Engineer II 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.

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.
• Support 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.
• Support the 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 to support Software related CAPA.
• Support Design 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:

• Bachelor's Degree in Computer Science or Software/Electrical Engineering/Biomedical Engineering or other Engineering disciplines
• 2+ years of transferable working experience
• Working knowledge of testing process and methodologies
• Manual system level testing experience in a regulated environment
• Understanding of Software Development Life Cycle Processes per IEC 62304
• 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 many 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
• Some 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)
  

U.S. Pay Transparency and Disclosure

Among other requirements, Boston Scientific maintains specific prohibited substance testing requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a drug test as a pre-employment requirement. The goal of the drug testing is to increase workplace safety in compliance with the applicable law.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.