Program Manager

• Experience: proven experience in a senior engineering or management role within a medical technology, life sciences, or healthcare company.
• Product Development Expertise: Extensive experience in both hardware and software product development, with a focus on medical devices, life science applications, or IoT solutions for healthcare.
• Digital & AI Knowledge: Strong background in the application of AI and digital technologies in healthcare settings, with a track record of successful product delivery.
• Regulatory Expertise: In-depth knowledge of FDA regulations and experience with regulatory submissions, including 510(k), PMA, and other relevant pathways.
• Leadership & Collaboration: Strong leadership skills with a proven ability to manage cross-functional teams, mentor engineers, and collaborate effectively with senior leadership.
• Communication Skills: Exceptional communication and problem-solving abilities, with the capacity to drive innovation and resolve complex technical challenges.
• End-to-End Product Management: Proven ability to manage product development from concept through commercialization, ensuring successful product launches and scalability.

Preferred Qualifications:

• Experience in IoT-enabled medical devices and connected health technologies.
• Familiarity with Agile methodologies and software development life cycles.
• Experience working with multidisciplinary teams in fast-paced environments.
• Experience with international regulatory standards and submission processes