Program Manager

Deepsight-Technology; Santa Clara (CA); Vor Ort; USD 150.000 - 190.000; Vollzeit

Zusammenfassung

DeepSight Technology is seeking an experienced Program Manager to lead complex programs for next-generation ultrasound systems and software features through development to commercial launch.

The ideal candidate will manage regulated medical device product development, drive cross-functional teams, and ensure successful regulatory submission and execution within ISO 13485 frameworks. Up to 20% travel may be required.

Qualifikationen

• 8+ years in Program Management for regulated medical devices.
• Experience leading hardware-software integration programs.
• Understanding FDA standards and 510(k) submissions.

Aufgaben

• Drive complex product programs from concept to commercial launch.
• Mitigate risks and ensure high-quality imaging solutions.
• Implement Agile practices and provide transparent program analytics.
• Lead governance and stakeholder communication across milestones.
• Oversee clinical evaluations for validation and regulatory submission.
• Coordinate multi-disciplinary teams including Engineering, Regulatory, and Manufacturing.

Kenntnisse

PM leadership

Regulated medical devices

FDA 510(k) process

QMS/ISO 13485

Cross-functional leadership

Agile methodologies

Regulatory submissions

Travel up to 20%

Ausbildung

MS in Mechanical, Electrical, or Biomedical Engineering

Jobbeschreibung

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.