SaMD Senior Manager

Kaliber AI is hiring an experienced and talented SaMD AI/Engineering and V&V Manager to join our team and help us develop the next generation of AI-powered, surgical software solutions. We’re a highly collaborative, mission-driven company and are looking for someone who’s excited about what we’re building at Kaliber and eager to contribute to the development of our products.

AI/Engineering is integral to Kaliber’s work, and the SaMD AI/Engineering and and V&V Manager will play a central role in implementing the architecture necessary to achieve our product goals and vision. You will lead a team of both direct reports spanning AI/ML, engineering, and V&V, as well as contractors.​

Responsibilities
 

  • Plan and direct development of V&V and maintenance of SaMD products

  • Hire, train, direct, and develop a competent technical staff that can effectively carry out all required functions

  • Develop and mentor direct reports from  SaMD development, V&V (onshore and offshore)

  • Establish development plans and procedures by partnering with QMS and regulatory head

  • Direct system integration level testing activities for software medical devices

  • Translate customer needs and business requirements into testable software requirements and specifications by collaborating with product manager and architect

  • Develop, evaluate, implement and maintain technical quality assurance and control systems or reliability systems and standards pertaining to products

  • Oversee the investigation and evaluation of existing technologies

  • Guide the conceptualization of new methodologies and processes (e.g., software requirements management, software defect tracking)

  • Monitor documentation maintenance throughout all phases of research and development

  • Coordinate activities with outside suppliers and consultants to ensure timely delivery
     

Qualifications
 

  • Technical degree required

  • Technical team management experience required

  • Minimum of 5 years of relevant experience

  • Industry knowledge and experience in software medical devices

  • Proven track record of developing engineering solutions for complex problems

  • Strong systems engineering skills

  • Strong understanding of design controls for medical device development including software testing for medical device applications

  • Experience with medical device design and development processes that conform to FDA regulations/ISO standards for medical devices

 

Location
 

This position is open at either our St. Louis, MO or San Francisco, CA office. Some of our positions require employees to be on-site in the office to create a better collaborative and efficient work environment. Employees may have to visit customer sites including medical facilities. Depending on the site's health and safety guidelines, you may be required to have medical screenings or vaccinations to meet site requirements, which may include Covid-19 vaccination and/or testing.

Travel
 

Must be able to travel up to 25%.

Benefits
 

  • Competitive compensation, Series B equity

  • Medical, dental, and vision insurance

  • Unlimited vacation

  • Opportunity to collaborate with world-renowned surgeons to help shape the future of surgery

Contact
 

To apply for this position, send your resume to jobs@kaliberlabs.com

About Kaliber Labs

Kaliber is building an end-to-end suite of AI-powered, minimally invasive surgical software solutions to support patients, providers, and payors. We’re on a mission to develop technology that supports more accurate, consistent, and efficient surgical performance, unifies and streamlines the surgical journey, and facilitates personalized, evidence-based care.

Kaliber Labs is an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or veteran status. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.