Risk Management and Human Factors Engineer

Company & Culture

Welldoc®, a digital health leader revolutionizing cardiometabolic care, is integrating personalized, real-time and actionable insights into the daily lives of individuals living with cardiometabolic conditions, enabling improved health and outcomes. Welldoc’s comprehensive digital health platform provides AI-powered digital coaching across pre-diabetes, diabetes, hypertension, heart failure and weight and obesity management, with integrated mental wellbeing and sleep support. Welldoc’s flagship product, BlueStar®, is an FDA-cleared digital health solution that guides individuals through the complicated journey of living with diabetes by enabling them to self-manage their care while enhancing connections to their healthcare team. These capabilities are now integrated into the Welldoc platform, providing comprehensive and flexible support across conditions. Welldoc partners with health plans, health systems and employers with the goal of extending care, improving health and reducing costs. The company has achieved 11 510(k) clearances for diabetes functionality within its digital health platform, and an IP portfolio of 43 patents for its advanced AI and first-in-class tech. With over 75 clinical publications, Welldoc has also built an extensive library of clinical research, including many publications focused on the value of combining CGM with AI-powered digital health solutions. Welldoc is a thought leader in the evolving world of AI powered digital health and has been showcased in prestigious conferences and publications, including South by Southwest, Wall Street Journal and the Economist. Welldoc has been named the “Best Overall Digital Health Company” by MedTech Breakthrough. The company recently received the 2024 Innovation Award and was a finalist for the AI Excellence Award from Business Intelligence Group.

For more information, visit https://welldoc.com/. Follow us on LinkedIn and Twitter.

At Welldoc, we are focused on transforming healthcare by creating an environment that fosters collaboration, learning, and innovation. We value the personalities and experiences of every one of our team members, giving everyone the opportunity to thrive as we make our mission a reality.

Welldoc has been certified as a Great Place to Work for the last 3 years. If you are inspired by innovation and the power of cutting-edge science to help individuals live healthier lives, we would love to hear from you!

*Welldoc® Diabetes and Welldoc Diabetes Rx is an FDA-cleared medical device, intended for use by healthcare providers and their adult patients with type 1 or type 2 diabetes. For full labeling information, visit www.welldoc.com. The other Welldoc App products are non-FDA-cleared and intended to promote general wellness and education/self-management of various chronic disease states.

Job Purpose

Provide Human Factors and Risk Management expertise to advance safety and usability of Welldoc’s SaMD and Digital Health applications throughout the product development process by supporting risk management activities and championing user-centered design principles. This highly visible role will provide input to design and development across a variety of products at different stages, from concept through post-market surveillance.

Job Responsibilities

Collaboration and Communication

• Solve problems, think creatively, and provide innovative solutions in a fast-paced environment.
• Collaborate cross functionally with product development, clinical, marketing, quality, regulatory, and external vendors
• Serve as SME on project team; makes decisions and clearly communicates pertinent project/function information
• Serve as Function representative in internal/external audits and with regulatory authorities

Human Factors Engineering

• Develop use related requirements, study designs, HF plans and HF reports to drive design and to support regulatory submissions
• Conduct task analyses, focus groups, formative and summative testing, data collection, and root cause analyses
• Work cross functionally to design and develop prototypes
• Create and maintain Usability Engineering Files in compliance with the QMS and regulatory requirements
• Present findings and recommendations from usability studies to stakeholders

Risk Management

• Oversee the risk management process including risk identification, analysis, mitigation, monitoring, and reduction for each product release including conducting hazard analysis, HHA meetings, and preparing all risk documentation per SOP.
• Create and maintain Risk Management Files in compliance with the QMS and regulatory requirements
• Perform risk assessments as part of post-market monitoring in support of complaint risk analysis, field corrective actions, design changes, product life cycle sustaining efforts, and others.

Continuous Improvement

• Participate in ongoing professional development opportunities, internally and/or externally, and share learnings within functional group, core team, or full company meetings as appropriate.
• Keep abreast of emerging regulatory and industry trends regarding risk management and human factors.
• Continually research tools and methods to optimize efficiency

Job Requirements

• Minimum 3 years of relevant experience
• Bachelor’s degree in Engineering, Applied Psychology, Systems Engineering, Human Factors, or related field
• Ability to apply risk management and usability engineering principles to product research, development, and design
• Experience conducting or supporting Human Factors activities for medical devices a plus
• Experience with medical device product development, ISO 62366, ISO 14791
• Have strong project management skills and can work alone or in teams
• Hybrid work environment
• Ability to travel 10-20% to external vendors to conduct on-site testing (will vary with project needs)

Compensation & Benefits

Welldoc offers a competitive compensation package which, in addition to salary, includes generous PTO, medical insurance, dental insurance, vision care, life and disability insurance, retirement benefits and the opportunity to participate in health savings accounts and/or dependent care accounts. The anticipated salary range for this position is between 85-140K/year with the expectation that most candidates will fall around the midpoint of the range.

Upon receipt of a conditional offer of employment, you may be required to complete and clear a multi-panel drug screening process. This screening is in connection with requirements set by certain of the Company’s customers, with which you may be working