Manager, Clinical Research Engineering - Instruments (Future Forward team)

Intuitive•Sunnyvale, CA

11d•$159,000 - $269,000•Onsite

About The 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.

Requirements

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 skills—verbal, written, and presentation—tailored 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.
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.

Nice To Haves

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

Responsibilities

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 strategies—including pre-clinical and feasibility studies—to 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.
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.
Champion the organization’s 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 company’s strategic objectives.