Program ManagerPosition SummaryWe 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.
