Software Quality Engineer - Intellectt INC

Hello Everyone,

Greetings of the day.

This is Vydehi from Intellectt Inc. We currently have an opening for a Engineer, Software Quality - Principle with one of our medical device clients. If you or anyone you know is interested in this opportunity, please feel free to send your updated resume to Vydehi@intellectt.com or reach out to me directly at +1 732 355 7412

Role: Engineer, Software Quality - Principle

Location: Lake Forest, IL - 60045

Duration: 12 Months

Key Responsibilities:

• Design, develop, and maintain software and interface specifications.
• Write, test, and troubleshoot software code and scripts.
• Create and execute test plans, analyze results, and resolve issues.
• Perform risk and hazard analyses to meet safety and regulatory standards.
• Collaborate with teams to gather and validate software requirements.
• Analyze and resolve software failures, implementing corrective actions.
• Review and provide feedback on project documentation, code, and procedures.
• Lead design reviews and ensure project deliverables meet quality standards.
• Comply with FDA regulations, Quality Management Systems (QMS), and company policies.
• Mentor junior engineers and support team objectives.

Qualifications:

• Bachelor's degree in Software Engineering, Computer Science, or a related field.
• 10+ years of software development and testing experience.
• Strong skills in software design, debugging, and testing methodologies.
• Knowledge of regulatory standards for medical devices (e.g., FDA, ISO 13485).
• Excellent communication, problem-solving, and organizational skills.
• Ability to travel up to 10%, including internationally.

Preferred Skills:

• Familiarity with IEC 62304 and ISO 14971 standards.
• Experience with automated testing and software debugging tools.