Clinical Product Analyst

About DrFirst

Here is a remarkable chance for you to join a thriving Healthcare IT company with established products, prestigious clients, substantial revenue, blue-chip institutional investors, and continuous growth. At DrFirst, you will collaborate with brilliant minds, tackling unique healthcare challenges on an unprecedented scale. Our culture is entrepreneurial, collaborative, and fast-paced—ideal for those who seek personal and professional growth while working alongside intelligent colleagues. If you're enthusiastic about pushing your limits, unlocking your potential, and thriving in a dynamic team, we're eager to connect with you!

Position Overview

The Clinical Product Analyst for SmartAI will ensure the highest standards of quality and compliance in our AI-driven healthcare solutions. This role is crucial in validating the accuracy, reliability, and safety of our products, with a particular focus on electronic prescribing systems. The Clinical Product Analyst will work closely with product managers, developers, data scientists, and other clinical experts to develop and execute comprehensive test plans and ensure our solutions meet regulatory requirements and exceed customer expectations. Additionally, the Clinical Product Analyst will be responsible for writing user stories, creating release notes, and contributing to the go-to-market plan.

Who will love this job

• Detail and Quality Oriented Individual: You have an eye for detail and can spot even the smallest inconsistencies or errors.
• Quality Champion: You are passionate about ensuring products meet the highest quality standards and are committed to continuous improvement.
• Analytical Thinker: You excel at analyzing complex systems and processes to identify potential issues and develop effective solutions.
• Collaborative Worker: You thrive in a team environment and enjoy working with cross-functional teams to achieve common goals.
• Proactive Problem-Solver: You take initiative to identify and address issues before they become critical problems.
  
  

What You Will Work On

• Develop and implement comprehensive test plans and strategies for AI-driven healthcare products, focusing on clinical accuracy and regulatory compliance.
• Conduct thorough testing of product functionalities, including manual and automated tests, to ensure product reliability and performance.
• Validate the clinical accuracy of AI models and algorithms, ensuring they meet industry standards and regulatory requirements.
• Identify, document, and track defects and issues, working closely with the development team to ensure timely resolution.
• Write detailed user stories that clearly define product requirements and acceptance criteria.
• Create comprehensive release notes to document new features, enhancements, and bug fixes for each product release.
• Ensure compliance with healthcare regulations, standards, and guidelines, including HIPAA, FDA, and other relevant authorities.
• Conduct risk assessments and develop mitigation strategies to address potential quality and compliance issues.
• Prepare and maintain detailed test documentation, including test cases, test scripts, and test reports.
• Collaborate with product managers, developers, data scientists, and clinical experts to understand product requirements and use cases.
• Contribute to the go-to-market plan, including market analysis, competitive analysis, and strategy development.
• Stay updated with the latest industry trends, best practices, and regulatory requirements related to healthcare and AI.
  
  

Qualifications

• Bachelor's degree with healthcare and/or medical focus; advanced clinical degree such as PharmD, MD, Master's or PHD highly preferred.
• Minimum of three (3) years of experience in clinical quality assurance or related roles, preferably within the healthcare or medical device industry.
• Prior electronic health record implementation experience a plus.
• Strong understanding of healthcare regulations and standards, including HIPAA, FDA, and ISO 13485.
• Experience with Automated Testing Methodologies: Familiarity with various automated testing methodologies, such as unit testing, integration testing, functional testing, regression testing, and performance testing.
• Proficiency with Automated Testing Tools: Hands-on experience with automated testing tools such as Selenium, JUnit, TestNG, Cucumber, Robot Framework, Appium, and LoadRunner.
• Prior QA Testing with AI or Implementations: Proven experience in quality assurance testing for AI models or implementation projects, ensuring accuracy, reliability, and compliance with industry standards.
• AI/ML Testing Tools: Familiarity with AI/ML testing tools and frameworks such as TensorFlow Extended (TFX), DeepCode, and Apache MXNet.
• Familiarity with AI and machine learning concepts, particularly in healthcare applications.
• Excellent analytical, problem-solving, and decision-making skills.
• Strong attention to detail and ability to document and communicate complex issues clearly.
• Ability to work effectively in a cross-functional team environment.
• Strong organizational and time management skills, with the ability to manage multiple projects and priorities.
• Excellent written and verbal communication skills.
  
  

Physical Requirements

• 90% working at desk and phone, standing and moving throughout the (remote) office.
• 10% travel as per business requirements.
  
  

Benefits

We offer comprehensive benefits to keep you healthy as you grow in your life and career. Your merit-based compensation will reflect the impact your work has on the company and our customers.

Learn more about our benefits and professional development opportunities at www.drfirst.com.