AI/ML Design Quality Engineer

Location: Vista, CA 92081 (**Must be local- Onsite) W-2

Payrate: $$60hr (Weekly pay + Medical Benefits)

Duration: 3-6 month contract to turn permanent- based on performance

Hours: Full-time: M-F start time can be 8am-9am. Onsite

**Must be local- Onsite- W-2 POSITION - MUST HAVE WORKED IN THE US FOR THE LAST 5YRS

Our client’s mission is “Advancing Cancer Diagnostics, Improving Lives” is at the heart of their culture. Global leader in cancer diagnostics with the most comprehensive portfolio from biopsy to diagnosis. Join our diverse, global team of talented people, and be inspired to grow every day. Together, we’re working at the pace of change to improve patient lives with diagnostic tools that address the world’s biggest health challenges.

Job Overview:

The primary role of AI Quality Engineer is to lead the quality assurance efforts for AI-driven medical device software. In this critical role, the associate will oversee the lifecycle development and compliance activities of AI/ML models and ensure the highest standards of safety, effectiveness, and regulatory compliance. In this role, you will mentor junior engineers and collaborate with cross-functional teams including R&D, clinical, regulatory, and product management.

Responsibilities:

• Participate in cross-functional teams as the Quality Engineering representative supporting design controls, verification, validation, and Design History Files.
• Develop and lead comprehensive quality assurance strategies for AI/ML algorithms, ensuring compliance with applicable regulations and standards.
• Partners with data scientists, software engineers, and clinical experts to align AI/ML solutions with clinical requirements and regulatory expectations.
• Support Regulatory Affairs in preparing deliverables for global regulatory submissions, including FDA pre-submissions, 510(k),
• Drive risk management activities for AI/ML components, including hazard analysis and mitigation planning.
• Establish and promote best practices for AI/ML verification, validation, and lifecycle management.
• Evaluate AI model performance, robustness, bias, and fairness to ensure patient safety and clinical effectiveness.
• Lead root cause analysis and corrective/preventive actions for AI-related software issues.
• Mentor junior engineers and share expertise in AI quality and regulatory compliance.
• Stay current on advancements in AI quality assurance, regulation, and industry best practices.
• Meet company and departmental goals in the continuous improvement of all products, services and processes.
• Represent the AI quality function in internal and external audits, regulatory inspections, and cross-departmental meetings

Requirements:

• Bachelor’s degree Computer Science, Data Science, or a related technical field;
• **Must be local to apply- W-2 POSITION - MUST HAVE WORKED IN THE US FOR THE LAST 5YRS
• 3+ years of experience in the Quality Design field specialized in AI/Machine learning.
• Must have experience in AI/Machine learning
• Must have experience working in a medical device- regulated industry
• Requires proven ability to develop and execute risk management processes for AI systems.
• Experience with regulatory standards and guidance applicable to AI/ML, medical devices, and software as a medical device: SAMD (Software as medical Device) including, IEC 5338 and ISO 13485
• Experience with AI/Machine learning and cybersecurity
• Deep knowledge of AI/Machine learning algorithms, model validation, and evaluation techniques.
• Must be a team player and have excellent communication skills
• Requires a candidate who has out of the box thinking style
• Experience to sell ideas to others and able to train team members on AI and Machine learning methodologies
• Bonus: Bachelor’s degree in in Artificial Intelligence / Machine Learning (AI/ML) science

TCWGlobal is an equal opportunity employer. We do not discriminate based on age, ethnicity, gender, nationality, religious belief, or sexual orientation.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.