Site Reliability Engineer

4 weeks ago

Secaucus, United States Cynet Systems Full time
Job Description:

Pay Range $60hr - $65hr

Responsibilities:
  • 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, and validates product software and firmware requirements, security requirements and compliances.
  • Oversee design, development, and testing of software related to all Neuromodulation product lines during their entire development life cycle, from the 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 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.
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 processes 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.
  • 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 for 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 application development.
  • Understand aspects of HIPAA and GDPR compliance practices.
  • ASQ Certified Quality Engineer (CQE) or ASQ Certified Software Quality Engineer (CSQE).
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