About iSono Health Inc.

iSono Health is a dynamic and rapidly growing early clinical-commercial stage medical device company dedicated to saving lives and transforming care through innovative robotics, AI, and 3D ultrasound technologies. 

At iSono Health, we're pioneering a new era of breast care. We believe every woman deserves access to fast, affordable, and comfortable screenings. That's why we developed ATUSA, the world's first AI-powered platform with a point-of-care, automated 3D ultrasound system.

To succeed here, you need to think like an entrepreneur, act like a leader, and execute with precision. We value individuals who take initiative, embrace challenges, and are excited to wear multiple hats. Creativity, resilience, and a commitment to excellence are essential as we push the boundaries of what’s possible in healthcare.

Our work is exciting because it’s meaningful. Together, we’re empowering women to take control of their health by expanding access to potentially lifesaving ultrasound technology. If you’re passionate about making a difference and ready to be part of a nimble, scrappy team that values impact over hierarchy, iSono Health is the place for you.

At iSono Health, success isn’t just about the work—it’s about the mindset. We’re a small but mighty team of dedicated individuals driven by a shared mission: revolutionizing women’s health and making a profound impact for patients and clinicians. With big ambitions and innovative plans, we thrive in a fast-paced, dynamic environment where every team member owns what they build.

Join us in transforming healthcare and be part of a team where every voice matters, every idea counts, and every action contributes to a greater purpose.

About the role

Role Overview:

We’re seeking a Technical Program Manager with strong engineering instincts and operations execution skills to lead and coordinate complex, cross-functional initiatives. This individual will work across engineering (hardware + software), manufacturing, clinical, and marketing teams to drive program success. You must have experience working in regulated environments (FDA, ISO 13485) and managing documentation and timelines with discipline and clarity.

This hands-on role is ideal for someone who can balance strategic oversight with tactical project execution—a builder, a doer, and a collaborator.

Key Responsibilities:

• Lead cross-functional engineering and operational programs from concept to deployment.
• Manage multiple project timelines and dependencies using tools like Jira, Trello, Confluence, and Microsoft Project 360
• Own and maintain QMS documentation, design controls, and risk management files in alignment with FDA regulations and ISO 13485 standards.
• Support audit preparation, manage corrective actions, and help implement process improvements.
• Ensure cross-department coordination between clinical, hardware, software, and marketing teams.
• Oversee the manufacturing process documentation and transfer to production
• Coordinate and facilitate design reviews, status updates, and documentation flow
• Support internal documentation processes and version control across teams

Qualifications:

Required Qualifications:

• 3–6+ years of experience in medical device aerospace, robotics, or regulated engineering environments
• Proven experience with project management and cross-functional coordination
• Experience supporting or leading audits and regulatory inspections
• Strong fluency in JIRA, Confluence, Microsoft Project 360, and/or Trello
• Must be able to work Pacific Standard Time hours
• Strong written and spoken English fluency
• Exceptional organizational skills and attention to detail
• Proactive, resourceful, and adaptable in dynamic startup environments

Preferred Qualifications:

• Bachelor’s or Master’s degree in Engineering (Mechanical, Biomedical, Electrical) or related field
• Familiarity with FDA requirements, ISO 13485, and QMS best practices
• Experience in R&D project management or Project Management Certifications (PMP)
• Hands-on familiarity with hardware or ultrasound systems
• Experience working in a hardware/software integration environment
• Exposure to clinical studies or healthcare operations

Why Join?

• Work at the forefront of AI-powered, accessible healthcare
• Be part of a mission-driven team saving lives through earlier cancer detection
• Shape the future of a category-defining medical device
• Thrive in a high-growth, fast-paced startup environment with a strong culture of impact
• Significant exposure to the management team and the industry leaders.
• Remote flexibility and cross-functional leadership opportunities