Digital Architect - MedTech

HCLTech is looking for a highly talented and self- motivated Digital Architect – MedTech to join it in advancing the technological world through innovation and creativity. Job Title: Digital Architect – MedTech Position Type: Full-time Location: Pleasanton, CA/Remote Role/Responsibilities Define and maintain end-to-end digital architecture for connected devices, mobile/web applications, and cloud platforms Develop reference architectures for IoT-enabled medical devices and digital therapeutics Lead architecture design reviews and governance processes Align digital strategy with business and clinical objectives 2. MedTech & Regulatory Compliance Ensure architecture complies with healthcare regulations (FDA, MDR, HIPAA, GDPR) Design systems aligned with IEC 62304 , ISO 13485 , and ISO 14971 Support software classification and risk management processes Collaborate with Quality and Regulatory Affairs teams Qualifications & Experience Bachelor’s or Master’s degree in Computer Science, Engineering, or related field 8–12+ years in software architecture, with at least 3–5 years in MedTech or regulated healthcare environments Strong knowledge of medical device software lifecycle standards Experience with IoT device connectivity and secure firmware/software integration Familiarity with FDA 21 CFR Part 820, EU MDR, and SaMD frameworks Expertise in cybersecurity best practices for medical devices Desired Qualifications Experience with Software as a Medical Device (SaMD) Experience integrating with major EHR vendors (e.g., Epic, Cerner) Knowledge of AI/ML applications in medical devices Certification in cloud architecture (AWS/Azure/GCP) Pay and Benefits Pay Range Minimum: $185,000 per year Pay Range Maximum: $225,000 per year HCLTech is an equal opportunity employer, committed to providing equal employment opportunities to all applicants and employees regardless of race, religion, sex, color, age, national origin, pregnancy, sexual orientation, physical disability or genetic information, military or veteran status, or any other protected classification, in accordance with federal, state, and/or local law. Should any applicant have concerns about discrimination in the hiring process, they should provide a detailed report of those concerns to View email address on click.appcast.io for investigation. A candidate’s pay within the range will depend on their skills, experience, education, and other factors permitted by law. This role may also be eligible for performance-based bonuses subject to company policies. In addition, this role is eligible for the following benefits subject to company policies: medical, dental, vision, pharmacy, life, accidental death & dismemberment, and disability insurance; employee assistance program; 401(k) retirement plan; 10 days of paid time off per year (some positions are eligible for need-based leave with no designated number of leave days per year); and 10 paid holidays per year How You’ll Grow At HCLTech, we offer continuous opportunities for you to find your spark and grow with us. We want you to be happy and satisfied with your role and to really learn what type of work sparks your brilliance the best. Throughout your time with us, we offer transparent communication with senior-level employees, learning and career development programs at every level, and opportunities to experiment in different roles or even pivot industries. We believe that you should be in control of your career with unlimited opportunities to find the role that fits you best. #J-18808-Ljbffr