Boston Scientific-posted 7 months ago
$79,700 - $151,400/Yr
Full-time • Mid Level
Hybrid • Santa Clarita, CA
Miscellaneous Manufacturing

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. At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model requiring employees to be in our local Valencia, CA office at least three days per week.

  • 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 compliance.
  • 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.
  • Bachelor's degree in Software/Electrical Engineering/Biomedical Engineering.
  • 4+ years of working experience in software engineering and/or testing.
  • 2+ years experience in Programming Languages such as C#, C++, Swift, Node.js, Java/JavaScript, Cloud, Windows, iOS, Android, Python, LabView.
  • Manual system level testing experience.
  • Understanding of Software Development Life Cycle Processes per IEC 62304.
  • Master's degree in Computer Science or Software/Electrical Engineering.
  • 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).
  • 401k
  • health_insurance
  • dental_insurance
  • vision_insurance
  • life_insurance
  • disability_insurance
  • tuition_reimbursement
  • paid_holidays
  • employee_discount_programs
  • professional_development
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