Description

Key Responsibilities

• Provide design quality support for software and software-as a medical device development programs from concept through transfer to manufacturing.
• Ensure compliance with applicable design control, software lifecycle, and risk management requirements.
• Review and contribute to system requirements, software requirements, architecture, and design documentation.
• Support development of verification and validation strategies for software, system, and integration testing.
• Partner with engineering, product development, regulatory, clinical, and quality teams to resolve design quality issues.
• Evaluate software development deliverables for completeness, traceability, and regulatory readiness.
• Support risk management activities, including hazard analysis, software-related risk evaluation, and mitigation verification.
• Participate in design reviews and provide constructive feedback to improve product quality, safety, and compliance.
• Assist in root cause analysis and corrective action activities related to design or software quality issues.
• Mentor less experienced engineers on design quality practices, documentation expectations, and compliance requirements.
• Contribute to continuous improvement initiatives for design quality processes, tools, and templates.

Required Experience:

• Software coding experience (C, C++, Java, Python)
• Software Risk Assessment
• Software Verification and Validation
• Bachelor's or Masters in Engineering degree
• Years’ Experience Required: 5 + years
• 2+ years of medical device experience

Key Skills

Education

Bachelor's or Master's degrees