Primary Function of Position:
The Program is responsible for leading and executing the full product development lifecycle of medical device capital systems, from initial concept through commercial launch. This role requires deep expertise in medical device development, regulatory pathways, operations, and cross-functional project management. The Program Manager serves as a key driver of product innovation, compliance, and operational excellence within the organization. The Program Manager provides strategic leadership and tactical execution across all stages of product development, including concept generation, design, prototyping, verification and validation, regulatory submissions, manufacturing transfer, and launch.
What you'd do
- Partner with product, technical, and functional leaders to shape program strategy, roadmap priorities, and execution plans.
- Align engineering, clinical, operations, regulatory, and product teams to meet program and portfolio goals.
- Facilitate program reviews and structured decisions to resolve issues, balance trade-offs, and maintain momentum.
- Lead cross-functional negotiations, resolve root-cause disputes, and build sustainable stakeholder alignment.
- Create concise executive narratives and reports that integrate analysis, recommendations, risks, and trade-offs.Product & Design Development
- Lead cross-functional teams through concept development, design iteration, prototyping, verification/validation, and design transfer to manufacturing.
- Resolve cross-functional dependencies across subsystem teams, external partners, manufacturing, regulatory, and commercial functions.
- Partner with design, clinical, human factors, and engineering teams to ensure product requirements, usability, and performance criteria are met.
- Lead design control and business reviews, ensuring governance, compliance, accountability, and timely escalation.Operational Execution
- Drive manufacturing readiness, including process development, supply chain coordination, build readiness, and launch planning.
What they want
- Bachelor’s degree in Mechanical, Electrical or Biomedical Engineering or a related technical field; advanced degree preferred.
- At least a minimum of 10 years' experience leading complex medical device development programs, including capital equipment or system-level products, from concept through commercial launch.
- In-depth knowledge of medical device regulatory pathways (FDA, EU MDR, ISO 13485), submission requirements, and quality system regulations.
- Proven ability to lead and influence cross-functional teams at multiple levels of the organization.
- Experience collaborating with engineering, operations, regulatory, quality, and clinical teams throughout all development phases.
- Exceptional communication and stakeholder-management skills.
- Ability to handle ambiguity effectively and oversee multiple large projects at once
- Advanced program planning skills, including WBS, dependency management, critical path analysis, scope control, risk management, and governance reporting.
- Ability to coach peers on stakeholder engagement, communication, scheduling discipline, and program management tools.
- Experience evaluating trade-offs across product features, customer needs, manufacturability, and cost.Preferred
About Intuitive Surgical · Engineering
It started with a simple idea: what if surgery could be less invasive and recovery less painful? Nearly 30 years later, that question still fuels everything we do at Intuitive. As a global leader in robotic-assisted surgery and minimally invasive care, our technologies—like the da Vinci surgical system and Ion—have transformed how care is delivered for millions of patients worldwide.
We’re a team of engineers, clinicians, and innovators united by one purpose: to make surgery smarter, safer, and…