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Embedded Systems Quality Assurance Specialist

2 months ago

Buffalo, New York, United States DeBellis Catherine & Morreale - Corporate Staffing Full time

Position Overview: We are looking for a skilled Quality Assurance Engineer with a robust background in embedded Linux systems and a thorough understanding of medical device software regulations. This role is vital in ensuring that our medical devices adhere to rigorous industry standards and regulatory frameworks.

Key Responsibilities:

  • Manage the complete lifecycle of bug tracking and feature enhancements, ensuring all modifications are well-documented and linked to specific requirements.
  • Collaborate closely with development teams to conduct thorough investigations, implement accurate fixes, and perform comprehensive testing of software issues.
  • Create, execute, and document detailed test plans for the validation and verification of software functionalities, ensuring compliance with FDA 510(k) requirements.
  • Establish and maintain CI/CD pipelines to automate testing processes, enhancing the efficiency of the development cycle.
  • Engage in the development and review of system requirements to guarantee testability and traceability in accordance with medical device regulations.
  • Offer technical guidance and support to team members regarding best practices in software quality assurance.
  • Stay informed about regulatory standards impacting software quality assurance in the medical device sector, including:

FDA's 21 CFR Part 820 for quality system regulations

IEC 62304 for medical device software life cycle processes

ISO 13485 for medical device quality management systems

ISO 14971 for risk management

Qualifications:

  • Bachelor's degree in Computer Science, Electrical Engineering, or a related field, or equivalent experience.
  • A minimum of 3 years of experience in quality assurance for embedded systems, ideally within the medical device industry.
  • Strong programming proficiency in C and Python.
  • In-depth knowledge of Linux operating systems and kernel-level testing.
  • Experience with CI/CD tools and methodologies.
  • Familiarity with regulatory standards and documentation requirements pertinent to class 2 medical devices and 510(k) submissions.
  • Exceptional analytical, problem-solving, and communication skills.

Preferred Qualifications:

  • Experience with i.MX7 processor, STM32, AVR, or similar hardware.
  • Certification in Quality Assurance or Software Testing.

Note: Candidates must currently reside in the Buffalo/Rochester, NY area. Relocation assistance is not available.