Manager, Clinical Research Engineering

Primary Function of Position

The Manager Clinical Research Engineering Instruments will serve as a technical and clinical leader in the design and development of new product instruments and tool concepts guiding programs from early concept through commercial launch. Leveraging deep clinical scientific and engineering expertise this role will partner with engineers physicians interaction designers human factors specialists training teams technical publications and other internal and external stakeholders to shape product and procedural innovation. The Manager Clinical Research Engineering will lead clinical support for early-stage feasibility and confirmatory clinical studies including proctoring case observation and synthesis of clinical insights to inform technology advancement. Responsibilities include identifying and documenting user needs contributing to product requirements assessing clinical risk and providing design guidance throughout the Product Development Process (PDP). This role will also design develop and execute pre-clinical experimental strategies to evaluate device performance safety and usability ensuring readiness for commercial launch. Working closely with regulatory quality clinical affairs and finance teams. The manager Clinical Research Engineering will contribute to defining clinical indications shaping commercialization strategies and driving technologies from concept to market-ready products.

Essential Job Duties

Product Development

• Apply in-depth clinical knowledge and technical system understanding in defining and developing products based on clinical needs
• Collaborate with physicians and key clinical users on clinical procedure development and understanding product feedback
• Clearly define clinical need and requirements for product
• Develop test models and test methods for clinically relevant product evaluations.
• Assess potential clinical risks and propose mitigations as an input to product design
• Provide strategic leadership in both individual and team leader capacity for the design and development of new product concepts from early feasibility through commercial launch leveraging deep clinical scientific and technical expertise.
• Leadership for team to conduct comprehensive research into disease states procedural workflows and emerging medical technologies to establish subject-matter expertise and guide innovation strategy.
• Partner with marketing clinical and physician stakeholders to define market needs and translate them into user-centric platform procedure instrument and accessory designs.
• Lead and collaborate with engineers/CREs and clinicians to establish and validate clinical performance objectives safety considerations and usability targets for early-phase technologies.
• Architect manage and execute clinical de-risking strategiesincluding pre-clinical and feasibility studiesto accelerate technology readiness and ensure robust clinical adoption potential.
• Manage structured design iteration cycles incorporating internal evaluations and targeted feedback from key opinion leaders (KOLs) to refine concepts and mitigate risk.
• Define manage and implement pre-clinical evaluation protocols to support regulatory submissions and first-in-human trials.
• Support regulatory teams in preparing submission-ready technical and clinical documentation.
• Apply a data-driven analytical approach to identify opportunities for product enhancement and portfolio expansion.

Clinical Research & Innovation

• Manage planning and execution of early-stage feasibility pilot and pivotal clinical trials to inform technology development regulatory strategy and reimbursement pathways.
• Identify evaluate and prioritize product enhancements and new product opportunities based on clinical needs market trends and physician feedback.
• Gather analyze and synthesize clinical insights from case observations and study data to refine product requirements inform training programs and proactively address clinical risks.
• Direct prototype evaluations in clinical environments translating complex user feedback into actionable engineering requirements to accelerate development timelines.
• Drive the generation of intellectual property by conceptualizing novel clinical applications and technology innovations.

Management Responsibilities

• Champion the organizations vision values and strategic priorities in all decision-making and cross-functional interactions. Consistently demonstrates culture and values of the organization internally and externally
• Hire train and develop high performing staff and support their long term professional development. Coach and provide feedback on an ongoing basis.
• Take ownership of high-priority cross-disciplinary initiatives beyond core responsibilities to advance the companys strategic objectives.

Qualifications :

Required Skills and Experience

• Fluent in medical and procedural terminology with strong applied knowledge of human anatomy.
• Expertise in complex robotic systems instrumentation and associated software algorithms.
• Leadership with consistent high performance and emotional intelligence drive to be continual learner
• Extensive experience in operating room or interventional suite environments including direct collaboration with physicians and clinical staff.
• Demonstrated ability to capture interpret and integrate clinical feedback into product design and risk management processes.
• Strong mechanical and technical aptitude with exceptional spatial reasoning and understanding of complex mechanical systems.
• Advanced analytical skills to design execute and interpret clinical and pre-clinical studies drawing actionable conclusions.
• Proven ability to lead multi-disciplinary teams influence decision-making and resolve critical issues with urgency and precision.
• Deep familiarity with FDA and MDR Design Control processes risk management and regulatory compliance.
• Exceptional communication skillsverbal written and presentationtailored to diverse technical and executive audiences.
• Self-directed leader who thrives in dynamic environments operates effectively under pressure and maintains a high level of accountability.

Required Education and Training

• Minimum of a B.S. in Biomedical Engineering Mechanical Engineering or a closely related technical discipline; advanced degree (M.S. or Ph.D.) strongly preferred.
• 8 years of progressive experience and 1-3 years as people manager in clinical engineering product development and/or translational research within the medical device industry including significant exposure to complex capital equipment robotic systems or advanced minimally invasive technologies.
• Demonstrated track record of leading cross-functional programs from early concept through regulatory clearance and commercial launch with deep experience in both pre-clinical and clinical phases.
• Proven ability to integrate clinical technical and market insights into product requirements risk assessments and development strategies driving innovation while ensuring compliance with global regulatory standards.

Working Conditions

• Must be available to work full-time and commute/relocate to Sunnyvale CA.
• Up to 30% travel. Some international travel will be required.
• Primary Location: Sunnyvale CA.

Preferred Skills and Experience  

• Experience with on-site clinical trial support a plus.
• Experience with commercial product launch a plus.
• Familiar with intellectual property development and patent assessment

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

U.S. Export Controls Disclaimer:  In accordance with the U.S. Export Administration Regulations (15 CFR 743.13(b)) some roles at Intuitive Surgical may be subject to U.S. export controls for prospective employeeswho are nationals from countries currently on embargo or sanctions status.

Certain information you provide as part of the application will be used for purposes of determining whether Intuitive Surgical will need to (i) obtain an export license from the U.S. Government on your behalf (note: the governments licensing process can take 3 to 6 months) or (ii) implement a Technology Control Plan (TCP) (note: typically adds 2 weeks to the hiring process).  

For any Intuitive role subject to export controls final offers are contingent upon obtaining an approved export license and/or an executed TCP prior to the prospective employeesstart date which may or may not be flexible and within a timeframe that does not unreasonably impede the hiring need. If applicable candidates will be notified and instructed on any requirements for these purposes. 

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.

This position may be filled at a different job level than listed here depending on
business need and/or on the selected candidates experience knowledge and skills.
Compensation will be based primarily on the job level at which the role is filled and the
candidates qualifications consistent with applicable law.

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 compensation ranges are listed.

Remote Work :

No

Employment Type :

Full-time