Program Manager

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

Program Manager

DeepSight Technology is a rapidly growing ultrasound company dedicated to revolutionizing medical ultrasound imaging and interventional procedures. Using proprietary sensor technology and advanced AI, our platform (including the FDA-cleared NeedleVue™ LC1 Ultrasound System) delivers real-time, high-precision guidance to redefine clinical standards and patient outcomes.

Position Summary

We are seeking a highly experienced and results-oriented Program Manager to lead the complex, cross-functional programs required to bring DeepSight's next-generation ultrasound systems and software features from development to commercial launch. The ideal candidate will have experience managing product development programs within the medical device industry.

Responsibilities

• Drive complex product programs from initial concept/definition through commercial launch, ensuring successful product delivery and maximum team efficiency.
• Proactively identify and mitigate program risks, working with technical experts to reconcile system performance and image artifacts to achieve the highest possible quality imaging solution.
• Implement Agile methodologies and performance management tools to provide accurate, transparent reporting and analytics of program outcomes, specifically leading integration teams focused on complex hardware-software integration.
• Establish robust program governance and communication channels to proactively manage stakeholder expectations and secure high-quality, on-schedule delivery across all product milestones.
• Lead the strategic scoping and financial estimation for all new product initiatives and significant follow-on feature sets, translating technical complexity into clear business proposals.
• Oversee and support the planning and execution of clinical evaluations necessary for product validation and regulatory submission.
• Direct and align the efforts of a multi-disciplinary team, including Engineering (Hardware, Software, Ultrasound Imaging, Instruments, AI), Clinical, Regulatory, and Manufacturing partners.

• Act as a driver for all FDA 510(k) and international regulatory submissions, ensuring all activities adhere to ISO 13485 Design Controls and are fully documented in the Design History File (DHF).

Required Qualifications

• 8+ years of industry experience in Program Management, specifically bringing regulated medical device products to market.
• Master of Science (M.S.) degree in Mechanical, Electrical, or Biomedical Engineering, or a related technical field.
• Expert knowledge of medical device Quality Management Systems (QMS), including deep proficiency in FDA standards, ISO 13485, and 510(k) submission processes.
• Demonstrated mastery of project management methodologies, with a proven ability to define the critical path and manage projects using project management tools.
• Exceptional leadership skills in directing engineering teams, balancing competing priorities in a matrixed organization, and collaborating effectively with subject matter experts.
• Strong experience managing complex hardware and software integration programs, including balancing internal and external (contract manufacturing) resources.
• Excellent oral and written communication skills, with a track record of adapting quickly to change in a fast-paced environment.
• Willingness to travel up to 20%.

Preferred Qualifications

• Direct experience leading product development teams in ultrasound imaging or equivalent medical device technology.
• Prior experience with devices designed for Interventional Procedures.
• Experience in a start-up or rapidly scaling environment.