Design Control Engineer

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About TytoCare

TytoCare is transforming the way care is delivered by enabling leading health plans and health systems to provide remote physical exams, closing the care gap. TytoCare’s Home and Pro Smart Clinic solutions extend high-quality care into homes and community settings, including schools, work sites, urgent care centers, and rural clinics, while leveraging proven engagement models and one of the world’s largest proprietary multi-modal clinical datasets, built from millions of real-world encounters, to power our FDA-cleared, award-winning AI.

Founded in 2012, TytoCare is trusted by more than 240 leading organizations across the U.S., Europe, Asia, Latin America, and the Middle East. Our partners consistently see utilization rates six times higher than traditional telehealth, an average 8.5% reduction in total cost of care, and 11.3% fewer Emergency Department visits, with an average NPS of 83.

Responsibilities

• Support the maintenance and organization of the Design History File (DHF) documentation.
• Assist in completing documentation required for product releases in compliance with FDA, CE, ISO, and internal procedures.
• Provide administrative support for design control activities throughout the product development lifecycle.
• Support documentation related to software validation and traceability.
• Assist in preparing documentation for audits and regulatory submissions.
• Ensure documentation is accurate, complete, and properly filed in internal systems.

Requirements

• BSc in Biomedical Engineering, Biotechnology, Life Sciences, or a related field.
• 1+ years of experience in quality management / regulated medical device environments.
• Ability to manage multiple documents and tasks simultaneously.
• Strong computer skills.
• Proactive attitude and willingness to learn.
• Strong organizational and communication skills and high attention to detail.
• Prior experience in documentation/administrative roles – an advantage.