Senior Program Manager, SaMD New Product Development

Kaliber Labs is seeking an experienced and talented Senior Program Manager to join our team and help oversee development of our next-generation, AI-based intraoperative solutions.

The Senior Program Manager will be responsible for managing cross-functional product development teams and one- or more multi-year projects focused on the development of new products for Kaliber’s intraoperative product line. This role will lead all aspects of new product development from project initiation to commercialization and will be responsible for meeting agreed-upon milestones and deliverables, reporting core team progress, and communicating program recommendations, risks, and the resolution of any issues to the leadership team.

Responsibilities
 

  • Plan, develop and manage the execution of complex new product development program(s) from concept to launch

  • Develop, define, and execute project plans, schedules, budgets and deliverables and identify needed resources for projects and programs

  • Lead key projects including, but not limited to building project plans, assessing project resourcing and budgeting, and providing regular communication/updates regarding the status of the project(s)

  • Project financial metrics such as budget and COGS

  • Understand design control principles and manage gate-keeping, design freezes, design reviews, change control, sign-offs, etc. 

  • Establish and maintain program and product design history files

  • Organize regular team meetings to drive progress, track and mitigate risks, resolve roadblocks, and review action items

  • Generate necessary documentation and assist teams with creating project plans, protocols, reports, etc.

  • Work with external vendors and OEM partners to drive development milestones

  • Identify potential roadblocks early and implement countermeasures

  • Develop plans with core members to eliminate and/or mitigate risks. If risks cannot be mitigated within the core team, determine appropriate means to communicate and elevate issues to appropriate individuals within the organization

  • Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, company policies, operating procedures, processes, and task assignments

  • Other duties as assigned
     

Qualifications
 

  • Minimum of a bachelor’s degree in engineering or related discipline

  • 8+ years of end-end program management experience in engineering, R&D, and/or quality within a medical device/biomedical, high technology, and/or any other regulated industry

  • Experience with using and/or administering project management software

  • PMP certification preferred

  • Experience with Agile or similar document control system

  • Excellent written and verbal communication skills

  • Experience with software development lifecycles
     

Location
 

Preferably, this position will be located 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@kaliber.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.