Overview
AI / ML Design Quality Engineer
Location : Vista, CA 92081 (Must be local- Onsite)
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
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.
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;3+ years of experience in the Quality Design field specialized in AI / Machine learning.Must have experience in AI / Machine learningMust have experience working in a medical device- regulated industryRequires 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 13485Experience with AI / Machine learning and cybersecurityDeep knowledge of AI / Machine learning algorithms, model validation, and evaluation techniques.Must be a team player and have excellent communication skillsRequires a candidate who has out of the box thinking styleExperience to sell ideas to others and able to train team members on AI and Machine learning methodologiesBonus : Bachelor's degree in in Artificial Intelligence / Machine Learning (AI / ML) scienceTCWGlobal is an equal opportunity employer. We do not discriminate based on , , , , belief, or .
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.
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