Program Manager

DeepSight Technology; Santa Clara (CA); On-site; USD 170,000 - 240,000; Full time

Job summary

DeepSight Technology in Santa Clara, CA seeks an experienced Program Manager to lead next-generation ultrasound system programs from concept to commercial launch, coordinating hardware, software, regulatory, and clinical teams.

You will implement Agile practices, drive risk management, oversee FDA 510(k) submissions, and partner with manufacturers to deliver high-quality imaging solutions while meeting schedule and budget expectations.

Qualifications

• 8+ years of experience bringing regulated medical device products to market.
• MS in Mechanical, Electrical, or Biomedical Engineering.
• Expert knowledge of FDA standards and ISO 13485.
• Strong leadership and communication skills.
• Willingness to travel up to 20%.

Responsibilities

• Drive complex product programs from initial concept/definition through commercial launch.
• Mitigate program risks, coordinating hardware/software integration with technical experts.
• Implement Agile methodologies and performance management tools for transparent reporting.
• Establish robust program governance and communication across stakeholders.
• Lead the strategic scoping and financial estimation for new product initiatives.
• Oversee planning and execution of clinical evaluations for validation and regulatory submission.

Skills

Program management

Regulatory knowledge

Leadership

Agile methodologies

Cross-functional collaboration

Education

MS in Mechanical, Electrical, or Biomedical Engineering

Tools

Project management tools

Job description

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.

Salary: $170000 - $240000 per year