DeepSight Technology is a rapidly growing ultrasound company dedicated to revolutionizing medical ultrasound imaging and interventional procedures. Using proprietary sensor technology and advanced algorithms, our platform including the FDA-cleared NeedleVueTM LCI 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 DeepSights 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, Al, Clinical, Regulatory, and Manufacturing partners. • Act as a driver for all FDA 510k 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 510k 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.