Lead Program Manager, Ultrasound Medical Devices

deepsightinc; St. Louis (MO); On-site; USD 110,000 - 170,000; Full time

Job summary

DeepSight Technology is seeking an experienced Program Manager to lead cross-functional programs from development through commercial launch in the ultrasound space.

You will drive end-to-end product programs, manage risks, and implement Agile processes across hardware and software teams. The role requires strong leadership, regulatory know-how, and collaboration with Clinical, Regulatory, and Manufacturing partners in a fast-paced environment.

Qualifications

• 8+ years of experience bringing regulated medical device products to market.
• MS in Mechanical, Electrical, or Biomedical Engineering or related field.
• Expert knowledge of QMS, FDA standards, ISO 13485, and 510(k) submissions.
• Proven project management with critical path definition and tool usage.
• Strong leadership directing engineering teams and managing priorities.

Responsibilities

• Drive complex product programs from concept to commercial launch.
• Mitigate program risks with technical experts to achieve high-quality imaging solutions.
• Implement Agile methodologies and performance metrics for integration teams (hardware‑software).
• Establish governance and communications for on‑schedule delivery across milestones.
• Lead scoping and financial estimation for new product initiatives and follow-on features.
• Plan and execute clinical evaluations for product validation and regulatory submission.
• Align multi-disciplinary teams across Engineering, Clinical, Regulatory and Manufacturing.
• Drive FDA 510(k) and international submissions with Design Controls and DHF documentation.

Skills

Program management

Cross-functional leadership

Agile methodologies

Risk management

Education

MS in Mechanical/Electrical/Biomedical Engineering

Tools

PM tools

Job description

DeepSight Technology is seeking an experienced Program Manager to lead cross-functional programs from development through commercial launch in the ultrasound space.

You will drive end-to-end product programs, manage risks, and implement Agile processes across hardware and software teams. The role requires strong leadership, regulatory know-how, and collaboration with Clinical, Regulatory, and Manufacturing partners in a fast-paced environment.