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.

Responsibilities

• Identify and document user needs, contribute to product requirements, assess clinical risk, and provide design guidance throughout the Product Development Process (PDP).
• Design, develop, and execute pre-clinical experimental strategies to evaluate device performance, safety, and usability, ensuring readiness for commercial launch.
• Work closely with regulatory, quality, clinical affairs, and finance teams.
• Contribute to defining clinical indications, shaping commercialization strategies, and driving technologies from concept to market-ready products.

Qualifications

• 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 a 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.
• Prominent experience in leading multi-disciplinary teams, influencing decision-making, and resolving 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.

Required Education and Training

• A 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.