Future Forward, Director of Clinical Research Engineering

Primary Function of Position

The Future Forward Director of Clinical Research Engineering leads the strategic planning and execution of clinical engineering efforts across early-stage platform and technology development at Intuitive. This individual brings deep clinical and technical expertise along with proven leadership in people management and development cross-functional collaboration and resource stewardship.

This role is pivotal in translating user needs and clinical gaps into platform design de-risking strategies and clinical execution plans. It also involves overseeing a high-performing team of clinical research engineers and setting the standard for project planning budget forecasting timeline execution and cross-functional alignmentall in service of delivering safe effective and innovative medical platforms and novel technologies to address unmet needs.

Essential Job Duties

Team Leadership and Development

• Director lead mentor and grow a team of clinical research engineers focusing on both individual development and organizational capability.
• Foster a high-performance values-driven culture focused on accountability transparency and innovation.
• Anticipate organizational capability needs and proactively recruit or develop team members to meet existing and evolving business demands.

Strategic Program Leadership

• Serve as the primary clinical engineering leader and director for early-stage robotic platform development within Future Forward.
• Establish and oversee clinical development strategies for preclinical and clinical evaluation phases ensuring alignment with regulatory reimbursement and commercial goals.
• Define and manage program goals timelines and budgets across multiple concurrent projects with varying complexity and risk levels.
• Drive alignment between engineering clinical regulatory and commercial functions through effective communication and clear prioritization frameworks.

Project Planning and Resource Management

• Develop and manage integrated program plans Gantt timelines resource loading and cross-functional dependencies.
• Optimize allocation of clinical engineering talent labs and capital resources across multiple projects.
• Own clinical engineering budget forecasting and ensure disciplined use of company resources aligned with portfolio objectives.
• Ensure all programs are progressing according to plan managing risks resolving blockers and adjusting resources as needed.

Innovation and Clinical Integration

• Lead and directr development of novel evaluation models procedural workflows and experimental designs to accelerate technology iteration and maturity.
• Oversee prototype evaluation activities in clinical labs ensuring clear translation of insights to design and systems engineering teams (both qualitative and quantitative).
• Guide the creation of clinical risk assessments and clinical validation strategies to support design iteration and regulatory filings.

Stakeholder Collaboration

• Serve as a primary clinical voice in early-stage programs influencing cross-functional peers and senior leaders.
• Engage with KOLs surgeons and external experts to pressure-test clinical use cases and inform platform direction.
• Collaborate with regulatory reimbursement and product management teams to shape evidence generation plans.

Execution of Early Clinical Studies

• Lead clinical strategy and execution of preclinical studies and early feasibility trials to de-risk new platforms.
• Lead clinical engineering team through support of clinical studies including larger scale studies such as support of qualified registries and randomized controlled trials.
• Drive protocol design site selection IRB engagement and real-time response to study execution challenges.
• Support eventual scale-up and transition to clinical affairs for pivotal studies and commercial readiness.

Qualifications :

Requirements
In order to adequately perform the responsibilities of this position the individual must have:

• Advanced degree (MS or PhD preferred) in Biomedical Engineering Mechanical Engineering or a related technical discipline with direct application to medical device design and clinical integration.
• Minimum 12 years of hands-on experience in medical device development with at least 5-7 years in clinical engineering leadership roles overseeing cross-functional teams through all phases of product developmentconcept preclinical first-in-human (FIH) early feasibility and traditional clinical studies.
• Proven track record of leading complex multi-site preclinical and clinical studies including protocol design regulatory strategy interface and real-time clinical decision support.
• Demonstrated expertise in translating unmet clinical needs into engineering requirements including authorship of product requirement documents (PRDs) clinical risk analyses (CRA) usability risk assessments (URA) and design input documentation.
• Strong technical knowledge in areas including robotic systems surgical instrumentation embedded software interaction and procedural workflows in minimally invasive surgery or interventional therapeutics.
• Deep familiarity with design control processes FDA QSR or MDR compliance.
• Expert-level ability in clinical risk identification and mitigation including development and execution of validation strategies to de-risk usability and safety for novel technologies.
• Skilled in project planning and execution using tools such as Microsoft Project Smartsheet or equivalent; demonstrated ability to model resource requirements develop multi-phase program timelines and manage cross-functional interdependencies.
• Demonstrated leadership in clinical lab and benchtop model development including mechanical test method design and prototype evaluation aligned with defined performance specifications.
• Experienced in working directly with surgeons key opinion leaders (KOLs) and multidisciplinary experts to gather synthesize and apply clinical feedback to early-stage technology development.
• Strong working knowledge of intellectual property development and a history of contributing to patent filings related to clinical applications device design or procedural innovation.
• Excellent written and verbal communication skills capable of clearly articulating complex clinical and technical information across stakeholders including regulatory engineering and commercial leadership.
• Proven ability to lead coach and develop high-performance teams; demonstrated success recruiting and retaining top clinical engineering talent
• Must be available to work full-time and commute/relocate to Sunnyvale CA
• Up to 25% travel. Some international travel may be required.
• Primary Location: Sunnyvale CA

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.

Intuitive is an Equal Opportunity Employer. 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.

Mandatory Notices

We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.

Preference will be given to qualified candidates who do not reside or plan to reside in Alabama Arkansas Delaware Florida Indiana Iowa Louisiana Maryland Mississippi Missouri Oklahoma Pennsylvania South Carolina or Tennessee.

We provide market-competitive compensation packages inclusive of base pay incentives benefits and equity. It would not be typical for someone to be hired at the top end of range for the role as actual pay will be determined based on several factors including experience skills and qualifications. The target salary ranges are listed.

Remote Work :

No

Employment Type :

Full-time