Digital Architect – MedTech

HCLTech; Santa Clara (CA); On-site; USD 195,000 - 245,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Pharmacy benefits

Life insurance

Disability insurance

Employee assistance program

401(k) plan

Paid time off

Paid holidays

Job summary

HCLTech is seeking a Digital Architect - MedTech to define and maintain end-to-end digital architecture for connected devices, mobile/web applications, and cloud platforms. You will develop reference architectures for IoT-enabled medical devices and digital therapeutics, and lead architecture reviews while aligning digital strategy with clinical objectives.

This role requires extensive knowledge of regulatory standards (FDA 21 CFR Part 820, MDR, SaMD) and strong cybersecurity practices across

Qualifications

• Bachelor’s or Master’s degree in Computer Science, Engineering, or related field.
• 8-12+ years in software architecture with 3-5 years in MedTech or regulated healthcare.
• 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.

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.

Skills

Software architecture

MedTech experience

IoT connectivity

Cybersecurity

Regulatory knowledge

Education

Bachelor’s or Master’s degree in CS/Engineering

Job description

HCLTech is seeking a highly talented and self-motivated Digital Architect - MedTech to join our team and contribute to advancing the technological landscape through innovation and creativity.

Job Title: Digital Architect - MedTech

Position Type: Full-time

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: $195,000 per year

Pay Range Maximum: $245,000 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 [e-mail] 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.