Ultrasound Systems PM - Regulated Medical Devices

deepsightinc; Santa Clara (CA); On-site; USD 180,000 - 240,000; Full time

Job summary

DeepSight Technology, a rapidly growing ultrasound company, seeks an experienced Program Manager to lead next‑generation ultrasound systems and software features from development to commercial launch.

You will drive cross-functional programs across hardware, software, AI, and clinical/regulatory teams, ensuring robust governance, timely milestones, and successful regulatory submissions in a fast-paced environment.

Qualifications

• 8+ years of PM experience bringing regulated medical devices to market.
• MS in Mechanical, Electrical, or Biomedical Engineering (or related field).
• Deep knowledge of QMS, FDA standards, ISO 13485, and 510(k) submissions.

Responsibilities

• Drive complex product programs from concept to commercial launch with high team efficiency.
• Mitigate program risks; reconcile system performance and imaging quality.
• Implement Agile practices and reporting for hardware-software integration programs.
• Establish governance and communication to meet all milestones on time.
• Lead scoping and financial estimation for new product initiatives and follow-on features.
• Plan and execute clinical evaluations for product validation and regulatory submissions.
• Coordinate Engineering, Clinical, Regulatory, and Manufacturing teams to align efforts.

Skills

Medical device PM

Cross-functional leadership

Regulatory knowledge (FDA 510(k))

Agile methodologies

Education

Master's degree in Engineering

Tools

PM software

Job description

DeepSight Technology, a rapidly growing ultrasound company, seeks an experienced Program Manager to lead next‑generation ultrasound systems and software features from development to commercial launch.

You will drive cross-functional programs across hardware, software, AI, and clinical/regulatory teams, ensuring robust governance, timely milestones, and successful regulatory submissions in a fast-paced environment.