The Sr. Technical Project Manager will be a key contributor to Cytovale’s system roadmap. They will work closely with Product Development Engineers (Mechanical, Electrical, Systems, and Software), Quality, and Manufacturing Operations to prioritize, plan, and execute instrument DFx and improvement projects. The position will coordinate and execute instrument hardware and software reliability improvements throughout the product development process. This person will demonstrate collaborative leadership, encouraging input and ownership from team members. This role is part of the engineering organization.

Responsibilities

• Define and direct prioritization, planning, and execution of improvements to the Cytovale System through cross-functional collaboration.
• Organize and coordinate hardware and software change projects.
• Identify critical path tasks, constraints, and mitigations to ensure on-time, on-budget project completion.
• Provide regular updates and presentations to senior management, highlighting risks and mitigation plans.
• Effectively communicate project risks and implement mitigations.
• Drive team efficiency through prioritization, collaboration, ownership, and continuous improvement.
• Develop and monitor performance metrics to track progress.
• Maintain project plans, budgets, and sprint plans throughout the development process.
• Coordinate internal and external project contributors.
• Ensure project management processes are followed and implement meaningful improvements.
• Lead productive retrospectives including lessons learned, process input and best practices.
• Ensure compliance with Cytovale’s QMS (ISO 13485) and FDA regulations.

Qualifications

• Bachelors Degree in a Science/Engineering field with 5 years of experience with complex medical devices (3 years managing projects).
• Successful history of supporting updates to a released product as well as early development within a 21 CFR Part 820 compliant quality management system.
• Strong technical capabilities and a hands-on working style.
• Experience mentoring junior team members
• Experience applying concurrent design principles during feasibility, development, and change management.
• Preferred: Agile Project Management Experience
• Preferred: Experience managing others
• Preferred: Proficiency experience in MS Project, ClickUp, Smartsheet, Jira or similar.
  Preferred: Knowledge of instrument electrical architectures and best practices to develop instruments to meet IEC 60601-1-2 and IEC 61010 EMC/EMC standards.

Requirements

• This position will be based in the San Francisco Bay Area (S. San Francisco).
• Ability to work in the United States.
• Role is up to 4 days per week onsite to carry out role functions. Up to 20% domestic travel.

Who you are

• Excellent communicator.
• Fast-learner with a “can-do” attitude and an ability to work independently.
• Desire to work in a high velocity startup where collaboration is prized.
• You have a passion for our mission and believe that what we are building is innovative enough to change the world.
• You thrive in a fluid environment, are comfortable with ambiguity and can shift gears quickly.