Senior Medical Device Program Manager – Ultrasound Systems

EmergencyMD; St. Louis (MO); On-site; USD 120,000 - 160,000; Full time

Job summary

DeepSight Technology is seeking an experienced Program Manager to lead cross-functional programs from development to commercial launch for next-generation ultrasound systems and software features. The role focuses on delivering high-quality imaging solutions and coordinating hardware-software integration across engineering, clinical, regulatory, and manufacturing teams.

The successful candidate will have 8+ years in regulated medical device program management, strong QMS/FDA knowledge, and

Qualifications

• 8+ years of program management experience in bringing regulated medical device products to market.
• Master of Science in Mechanical, Electrical, Biomedical, or related engineering field.
• Expert knowledge of QMS, FDA standards, ISO 13485, and 510(k) submissions."
• Demonstrated ability to define critical paths and manage projects with PM tools.
• Strong leadership in directing engineering teams and cross-functional collaboration.
• Experience balancing hardware and software integration with internal and external resources.
• Excellent written and oral communication, adaptable in a fast-paced environment.
• Willingness to travel up to 20%.

Responsibilities

• Drive complex product programs from concept through commercial launch.
• Identify and mitigate program risks with technical teams to achieve high-quality imaging solutions.
• Implement Agile methodologies and provide transparent reporting for program outcomes.
• Establish governance and communication channels to manage stakeholder expectations and on-schedule delivery across milestones.
• Lead strategic scoping and financial estimation for new product initiatives and feature sets.
• Oversee planning/execution of clinical evaluations for validation and regulatory submission.
• Coordinate multi-disciplinary teams including Engineering, Clinical, Regulatory, and Manufacturing.

Skills

Program management

Medical device industry

QMS & FDA ISO 13485

Project management tools

Leadership

Hardware-software integration

Regulatory submissions

Communication

Travel

Education

MS in Mechanical, Electrical, or Biomedical Engineering

Job description

DeepSight Technology is seeking an experienced Program Manager to lead cross-functional programs from development to commercial launch for next-generation ultrasound systems and software features. The role focuses on delivering high-quality imaging solutions and coordinating hardware-software integration across engineering, clinical, regulatory, and manufacturing teams.

The successful candidate will have 8+ years in regulated medical device program management, strong QMS/FDA knowledge, and