Johnson & Johnson
Senior Clinical Engineer - Monarch Urology
Johnson & Johnson, Santa Clara, California, us, 95053
Overview
Senior Clinical Engineer for the Monarch Urology team in Santa Clara, CA. Robotics and Digital Solutions, part of Johnson & Johnson MedTech, seeks a Senior Clinical Engineer to define user needs, establish clinical and engineering requirements, consider clinical risks, and identify solutions to guide product development. High autonomy and growth opportunities. Responsibilities
Become the domain expert on KUB anatomy, kidney stone standard of care treatments, and clinical procedures. Collaborate with cross-functional teams to discover, define, develop, and validate 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 for clinical performance. Develop clinical workflows, conduct risk assessments, and propose mitigations for hazards. Collaborate with pre-clinical and regulatory teams to support pre-clinical studies. Write plans, protocols, conduct testing, and report results of design validation per FDA regulations. Support development of training materials, user manuals, labeling, and assessments. Support initial product launch and early customer site activations. Qualifications
Bachelor's degree in engineering (Biomedical, Mechanical) required; advanced degree assets. Paths include: undergrad + 5+ years medical device experience OR Master’s + 4+ years OR PhD + 2+ years. Experience collaborating with physicians to gather feedback and identify unmet needs. Strong communication and collaboration skills across R&D, PM, human factors, education teams. Experience designing and conducting pre-clinical studies for performance and safety. Ability to identify clinical risks and conduct harm analyses. Experience developing Design Validation strategy, protocols, and testing; creating design requirements. Knowledge of endoscopic/laparoscopic procedures and OR workflow beneficial; surgical robotics concepts helpful. Familiarity with FDA regulations and IEC/ISO standards; willingness to travel up to 15% (domestic/international). Perks
Generous vacation policy; commute assistance (SF shuttle, transit stipend). Compensation
The anticipated base pay range for this position is 121,000 - 194,350 California Bay Area.
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Senior Clinical Engineer for the Monarch Urology team in Santa Clara, CA. Robotics and Digital Solutions, part of Johnson & Johnson MedTech, seeks a Senior Clinical Engineer to define user needs, establish clinical and engineering requirements, consider clinical risks, and identify solutions to guide product development. High autonomy and growth opportunities. Responsibilities
Become the domain expert on KUB anatomy, kidney stone standard of care treatments, and clinical procedures. Collaborate with cross-functional teams to discover, define, develop, and validate 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 for clinical performance. Develop clinical workflows, conduct risk assessments, and propose mitigations for hazards. Collaborate with pre-clinical and regulatory teams to support pre-clinical studies. Write plans, protocols, conduct testing, and report results of design validation per FDA regulations. Support development of training materials, user manuals, labeling, and assessments. Support initial product launch and early customer site activations. Qualifications
Bachelor's degree in engineering (Biomedical, Mechanical) required; advanced degree assets. Paths include: undergrad + 5+ years medical device experience OR Master’s + 4+ years OR PhD + 2+ years. Experience collaborating with physicians to gather feedback and identify unmet needs. Strong communication and collaboration skills across R&D, PM, human factors, education teams. Experience designing and conducting pre-clinical studies for performance and safety. Ability to identify clinical risks and conduct harm analyses. Experience developing Design Validation strategy, protocols, and testing; creating design requirements. Knowledge of endoscopic/laparoscopic procedures and OR workflow beneficial; surgical robotics concepts helpful. Familiarity with FDA regulations and IEC/ISO standards; willingness to travel up to 15% (domestic/international). Perks
Generous vacation policy; commute assistance (SF shuttle, transit stipend). Compensation
The anticipated base pay range for this position is 121,000 - 194,350 California Bay Area.
#J-18808-Ljbffr