Program Manager

DeepSight Technology-posted 1 day ago
Full-time • Manager
St. Louis, MO
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DeepSight Technology is a rapidly growing ultrasound company dedicated to revolutionizing medical ultrasound imaging and interventional procedures. Using proprietary sensor technology and advanced Al, our platform (including the FDA-cleared NeedleVueTM LCI Ultrasound System) delivers real-time, high-precision guidance to redefine clinical standards and patient outcomes. 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.

  • 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, onschedule 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 51 0(k) and international regulatory submissions, ensuring all activities adhere to ISO 13485 Design Controls and are fully documented in the Design History File (DHF).
  • 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%.
  • 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.
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