Senior Program Manager, SaMD New Product Development

Kaliber Labs is seeking an experienced Senior Program Manager, SaMD New Product Development, to join our team and help oversee development of our next-generation, AI-based intraoperative solutions. The ideal candidate has the expertise and desire to join a rapidly growing company with an ambitious vision to transform arthroscopic surgical care to the benefit of patients and surgeons alike.

 

In this role, you 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 program management for new product development, from project initiation to commercialization, and will be responsible for meeting agreed-upon milestones and deliverables, reporting and documenting 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)

  • Create project financial metrics such as budget and COGS

  • Understand medical device design control principles and manage gatekeeping, design freezes, design reviews, change control, sign-offs, etc. 

  • Establish and maintain project design history files

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

  • Assist team members in creating project documentation

  • 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

  • Perform other duties as assigned
     

Qualifications

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

  • 8+ years of end-to-end program management experience in engineering, R&D, and/or quality within a medical device or biomedical industries. 

  • 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

Position is located at either our San Francisco or Santa Clara, CA office. This role may also require visits to 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 10%.
 

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, submit resume and cover letter highlighting significant accomplishments to
jobs@kaliberlabs.com

About Kaliber Labs

Kaliber builds AI-powered solutions to meet the needs of patients, surgeons, and administrators in orthopedic surgery. Our intelligent software is designed to generate insights from surgical procedures—cut to close—and channel them into surgeon-centric tools to support quality, access, and cost of care. We aim to make surgeons’ lives better, empower patients, and make providers and payors more efficient.

 

Kaliber is proud to be an Equal Opportunity Employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex (including pregnancy), national origin, sexual orientation, age (40 or older), citizenship, marital status, disability, gender identity, genetic information, or Veteran status. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.