Senior Ultrasound Programs Manager

Deepsight-Technology; Santa Clara (CA); On-site; USD 150,000 - 190,000; Full time

Job summary

DeepSight Technology is seeking an experienced Program Manager to lead complex programs for next-generation ultrasound systems and software features through development to commercial launch.

The ideal candidate will manage regulated medical device product development, drive cross-functional teams, and ensure successful regulatory submission and execution within ISO 13485 frameworks. Up to 20% travel may be required.

Qualifications

• 8+ years in Program Management for regulated medical devices.
• Experience leading hardware-software integration programs.
• Understanding FDA standards and 510(k) submissions.

Responsibilities

• Drive complex product programs from concept to commercial launch.
• Mitigate risks and ensure high-quality imaging solutions.
• Implement Agile practices and provide transparent program analytics.
• Lead governance and stakeholder communication across milestones.
• Oversee clinical evaluations for validation and regulatory submission.
• Coordinate multi-disciplinary teams including Engineering, Regulatory, and Manufacturing.

Skills

PM leadership

Regulated medical devices

FDA 510(k) process

QMS/ISO 13485

Cross-functional leadership

Agile methodologies

Regulatory submissions

Travel up to 20%

Education

MS in Mechanical, Electrical, or Biomedical Engineering

Job description

DeepSight Technology is seeking an experienced Program Manager to lead complex programs for next-generation ultrasound systems and software features through development to commercial launch.

The ideal candidate will manage regulated medical device product development, drive cross-functional teams, and ensure successful regulatory submission and execution within ISO 13485 frameworks. Up to 20% travel may be required.