Senior Clinical Engineer - Monarch Urology

Role Summary

Senior Clinical Engineer for the Monarch Urology team, located in Santa Clara, CA. Responsible for defining user needs and engineering requirements, assessing clinical risks, and guiding product development for a leading medical robotic platform within the Monarch program.

Responsibilities

• Become the domain expert on KUB anatomy, kidney stone treatments, and relevant clinical procedures
• Collaborate with cross-functional teams to discover, define, develop, and validate a new product using clinical, technical, and design control knowledge
• Partner with physicians and clinical users to develop procedural techniques, gather feedback, and integrate insights into product iterations
• Identify unmet clinical needs, establish customer requirements, and provide clinical input to engineering design requirements
• Develop bench models and metrics to evaluate prototype designs, ensuring clinical performance requirements are met
• Develop clinical workflows, conduct clinical risk assessments, and propose mitigations for identified hazards
• Collaborate with pre-clinical and regulatory teams to support studies
• Write plans and protocols, conduct testing, and report results of design validation studies per FDA regulations
• Support developing customer training materials, user manuals, labeling, and assessments
• Support initial product launch and early customer-site cases

Qualifications

• Bachelor‚Äôs degree in engineering (Biomedical, Mechanical) required; advanced degree (Masters, PhD, MD) is an asset
• Either: A) Undergraduate degree with at least 5 years of related medical device experience OR B) Master‚Äôs with 4 years of related experience OR C) PhD with 2 years of related experience
• Experience collaborating with physicians to gather clinical feedback and identify unmet needs
• Strong communication and interpersonal skills for cross-functional collaboration
• Experience designing and conducting pre-clinical engineering studies for product performance and safety
• Ability to identify clinical risks and perform clinical harm analyses
• Experience developing Design Validation strategy, protocols, and testing
• Experience constructing customer and engineering design requirements
• Ability to synthesize technical and clinical inputs to make recommendations
• Knowledge of endoscopic/laparoscopic procedures and OR workflow beneficial
• Familiarity with surgical robotics concepts beneficial
• Understanding of medical device regulations (FDA, IEC, ISO) beneficial
• Travel up to 15% of the time (domestic and international) expected

Skills

• Clinical risk assessment
• Design validation and verification
• Product development and requirements management
• Cross-functional collaboration
• Communication and documentation
• Bench modeling and evaluation
• Clinical workflow development

Education

• Bachelor‚Äôs degree in Biomedical or Mechanical Engineering required
• Advanced degree (Masters/PhD/MD) asset

Additional Requirements

• Willingness to travel up to 15% of the time, internationally and domestically