Quality Assurance Engineer - Medical Device - Embedded Linux Systems

My client has developed a cutting edge patient bedside electro-mechanical device with Bluetooth connectivity with some AI technology.

This device will revolutionize this product category.

They need to add an experienced Quality Assurance Engineer with embedded Linux systems experience to their team...

Job Overview : We are seeking a dedicated Quality Assurance Engineer with significant expertise in embedded Linux systems and medical device software regulations to join our dynamic team.

This role is critical in ensuring our medical devices meet stringent industry standards and regulatory requirements. The successful candidate will possess a strong background in software engineering, with specific skills in C, Python, and Linux operating systems.

Experience with continuous integration and continuous delivery (CI / CD) processes is also essential. This position requires meticulous attention to detail and a strong commitment to ensuring software reliability and compliance with the 510(k) submissions for class 2 medical devices.

Responsibilities :

• Oversee and manage the entire lifecycle of bug tracking and feature enhancements from detection through resolution and validation, ensuring all changes are properly documented and traceable to specific requirements in the design matrix.
• Collaborate with development teams to ensure thorough investigation, accurate fixes, and robust testing of software issues.
• Write, execute, and document comprehensive test plans for validation and verification of software functionalities to ensure compliance with FDA 510(k) requirements.
• Integrate and maintain CI / CD pipelines to automate testing and improve the efficiency and effectiveness of the development cycle.
• Participate in the development and review of system requirements to ensure testability and traceability in compliance with medical device regulations.
• Provide technical guidance and support to other team members regarding best practices in software quality assurance.
• Maintain up-to-date knowledge of regulatory standards affecting software quality assurance in the medical devices field.

Standards include but are not limited to :

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, related field or equivalent experience
• Minimum of 3 years experience in QA embedded systems, preferably in the medical device industry.
• Strong programming skills in C and Python.
• Profound knowledge of Linux operating systems and kernel-level testing.
• Experience with CI / CD tools and practices.
• Familiarity with regulatory standards and documentation requirements specific to class 2 medical devices and 510(k) submissions.
• Excellent 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.

MUST currently be living in the Buffalo / Rochester, NY area. My client is not interested in relocating anyone. If you have ties to the WNY area and want to relocate yourself, you will be considered.