Program Manager

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

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.