Ventaris Surgical, Inc. Senior Manager, R&D, Capital San Carlos, CA · Full time

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About Ventaris Surgical

Ventaris Surgical is a venture backed medical device company founded in 2024 and headquartered in San Carlos, California. Backed by leading MedTech investors following a $30 million Series A financing, we are developing a next generation ureteroscopic system designed to help surgeons achieve more complete kidney stone clearance in a single procedure while reducing the physical and cognitive burden of treatment.

Kidney stone disease is one of the world's most common urologic conditions. Nearly 1 in 10 people will experience a kidney stone in their lifetime, and more than 500,000 people undergo kidney stone surgery in the U.S. each year. Yet today's tools make it difficult for surgeons to consistently achieve complete stone clearance. Our vision is simple: every patient stone free through a single procedure.

About the Role

Ventaris Surgical is seeking a Senior Manager of R&D, Capital to lead the development of our capital equipment platform and the team that builds it. This leader will own the technical direction, people, and execution of our capital system, including hardware and software, and will guide the program through the transition from pre commercial development, FDA clearance, and commercial launch.

The Senior Manager of R&D, Capital is a hands on leadership role responsible for developing and leading the engineering team behind our capital equipment. You will translate product objectives into executable plans, set priorities for your team, and drive cross functional deliverables through design, verification, regulatory submission, manufacturing transfer, and commercialization.

The ideal candidate is a proven people leader with a strong R&D background in capital equipment and enough technical depth to understand what the project needs, evaluate engineering tradeoffs, and set and meet realistic timelines. Experience taking products from pre commercial development into commercial use is essential.

Key Responsibilities

Team Leadership

• Lead and develop a team of engineers by setting clear goals, priorities, and accountability
• Recruit, mentor, and grow talent as the R&D organization scales
• Create a team culture rooted in ownership, technical rigor, and open communication

Capital Equipment R&D

• Own capital equipment development, including system architecture, subsystem integration, prototypes, test assets, verification, configuration control, serviceability, and cost targets
• Lead cross functional execution across mechanical, electrical, software, firmware, and systems
• Make sound technical decisions and tradeoffs that balance performance, schedule, cost, and risk

Software and Firmware

• Drive the software and firmware side of the capital system, including requirements, architecture decisions, hardware and software integration, and release planning
• Ensure software development follows the IEC 62304 lifecycle, with documentation and verification that support regulatory submission
• Partner with internal software engineering and external software resources to keep deliverables on schedule and aligned with system needs

Program Execution

• Own integrated project plans, schedules, dependencies, risks, and deliverables for the capital program
• Maintain visibility into the critical path and escalate decisions, resource constraints, supplier issues, and technical risks before they affect major milestones
• Coordinate applicable compliance activities, including electrical safety, EMC, usability, software lifecycle, risk management, and preparation for external testing
• Partner with Quality and Regulatory to ensure timely completion of design control, risk management, traceability, verification, validation, and submission deliverables
• Manage external engineering firms, contract manufacturers, suppliers, and test laboratories against defined schedules, deliverables, and acceptance criteria
• Support related single use device programs where they interface with the capital system, including requirements, performance testing, and system compatibility

Pre Commercial to Commercial Transition

• Lead the capital system through the transition from development to commercial readiness, including design transfer, pilot builds, manufacturing scale up, and service and support readiness
• Coordinate product readiness for integration testing, physician evaluations, animal studies, clinical use, demonstrations, and manufacturing transfer
• Provide concise, decision oriented program updates to R&D and company leadership

Requirements

• 8+ years of medical device product development experience with a strong R&D background in capital equipment
• Experience managing engineers with direct reports, including hiring, developing, and leading a team
• Technical depth to understand project needs, assess engineering tradeoffs, and build realistic timelines
• Experience leading or directly driving software and firmware development for capital equipment, including familiarity with IEC 62304
• Experience taking a medical device from pre commercial development through commercial launch
• Experience leading cross functional projects through medical device design controls
• Experience with complex electromechanical or capital equipment systems, including subsystem and system level integration
• Experience managing project schedules, budgets, risks, suppliers, and executive status reporting
• Strong written communication, technical documentation, and stakeholder management skills
• Ability to operate effectively in a fast paced environment with evolving priorities

Education

• Bachelor’s degree in engineering, biomedical engineering, or a related technical discipline
• Advanced degree in engineering or a related technical discipline preferred

Preferred Qualifications

• Experience with complex electromechanical medical or surgical systems
• Experience with sterile, single use devices that interface with reusable capital equipment
• Familiarity with FDA 510(k) submissions and standards such as IEC 60601, IEC 62304, ISO 14971, IEC 62366, and ISO 10993
• Experience with design transfer, process validation, supplier qualification, cost reduction, and sustaining engineering
• Experience building an R&D team in an early stage or venture backed company
• PMP certification or equivalent project management training

Key Attributes

• A people leader who develops engineers and builds strong, accountable teams
• Technically credible, organized, and comfortable challenging assumptions
• Proactive in identifying risks, dependencies, and unclear ownership
• Able to balance urgency with design control and documentation requirements
• Decisive and pragmatic, with strong follow through and attention to detail
• Willing to engage directly in builds, testing, troubleshooting, and supplier discussions

Measures of Success

• A capable, engaged capital R&D team is in place and delivering against clear goals
• Program milestones are achieved with risks identified and addressed early
• Hardware and software deliverables are integrated on schedule, with timelines that accurately reflect resources, dependencies, and the critical path
• Requirements, system interfaces, and ownership boundaries are clear
• Verification, regulatory, clinical, and manufacturing deliverables are completed with minimal late rework
• The capital system transitions efficiently from development into controlled, scalable manufacturing and commercial use

Why Join Ventaris

• High impact from day one: we are a small team, and every role is mission critical
• A clear, compelling vision: every patient stone free through a single procedure
• A rare moment to help define a new standard of care, at a point when the field is still shifting away from incremental improvements
• Backed by leading MedTech investors following a $30 million Series A financing
• A low ego, high accountability culture grounded in collaboration, candor, and conviction

Who We're Looking For

We are a values based company. Our values guide how we work and make decisions:

Collaboration: Time and attention are finite. Meetings are purposeful. Own your work, be accountable, and drive to closure. Asking for help is a strength, not a weakness.

Candor: Speak up early, directly, and respectfully. Debate ideas, not people. Raise concerns when they are small. Avoid politics, passivity, and condescension.

Conviction: Let the mission guide every decision. Make hard tradeoffs for the collective good. Focus on getting it right over being right. Challenge each other, then commit fully.

Ventaris Surgical is an equal opportunity employer and considers qualified applicants without regard to any characteristic protected by applicable law.