Clinical Development Engineering, Operations Lead

About the role

The CDE Operations Lead position plays a crucial role in supporting the Ion Endoluminal platform. Reporting to the Sr. Manager/Director of Clinical Development Engineering, they collaborate with various teams to ensure the successful delivery of new product solutions.

Responsibilities

• Own integrated planning across staffing, lab capacity, specimen demand and forecasting for the CDE program
• Leverage expertise to define, track, and drive key lab utilization metrics and dashboards
• Develop and monitor lab forecasts to inform program budgeting and identify potential operational constraints
• Build and scale training and onboarding programs for lab technicians and CDE team members, including tools and competency tracking
• Manage capital equipment, lab inventory, service contracts, and third-party vendors to ensure operational readiness and cost efficiency
• Ensure compliance with IACUC and all applicable regulatory and institutional lab standards
• Develop and implement SOPs and workflows to improve efficiency, quality, and scalability of lab operations
• Lead cross-functional planning and execution across Comparative Medicine, CDE, and Test Engineering teams
• Oversee end-to-end logistics for pre-clinical studies, physician engagements, and CDE events
• Develop evaluation frameworks and metrics to assess program performance and drive continuous improvement
• Identify operational risks and implement mitigation and contingency strategies
• Support and operationalize pre-clinical model development activities (adjust based on intent)

Qualifications

• Ability to understand complex products
• Experience in project coordination and managing multiple high priority projects
• Experience working in cross-functional teams and proven ability to cultivate collaboration across multiple disciplines to ensure project success
• Strong interpersonal skills: able to use tact and diplomacy to maintain effective working relationships, able to raise problems or challenges in a productive manner
• Prioritize critical issues with the ability to react quickly under pressure, and drive issues to closure by providing coordinated direction
• Creative in succeeding and applying simple solutions
• Strong project management, planning, decision making, negotiating and change management skills
• Self-starter needing minimal supervision
• Self-assured and able to react quickly under pressure
• Excellent verbal and written communications skills required including presentation of technical content

Required Education and Training

• Minimum B.S. in technical or medical fields with project management as a bonus
• Minimum of 6 years of industry experience with 2 years of relevant experience in people or program management
• Additional Information
• Due to the nature of our business and the role, please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19. Details can vary by role.
• We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws.