Staff Clinical Engineer

Role Summary

Staff Clinical Engineer for the Monarch Urology team in Santa Clara, CA. You will join a cross-functional team to define user needs, establish clinical and engineering requirements, consider clinical risks, and identify solutions to guide product development with high autonomy and growth opportunities.

Responsibilities

• Become the domain expert on KUB (Kidney Ureteral Bladder) anatomy, kidney stone standard of care treatments, and clinical procedures
• Utilize in-depth clinical, technical, and design control knowledge to collaborate with a cross-functional team to discover, define, develop, and validate a new product
• Partner with physicians and key clinical users to develop novel procedural techniques, gather product feedback, and integrate their insights into product iterations
• Discover unmet clinical needs, establish customer requirements and provide clinical input to engineering design requirements
• Apply clinical knowledge to develop bench models and metrics for evaluation of prototype designs to ensure clinical performance needs are met and maintained during development
• Develop new product clinical workflows, conduct clinical risk assessments, and propose effective mitigations for identified hazards
• Collaborate with pre-clinical and regulatory teams to support and advance pre-clinical studies
• Write plans, protocols, conduct formal testing, and report results of Design validation studies as required by FDA regulations
• Support developing customer training materials, user manuals, labeling, formative and summative assessments
• Support initial product launch and initial cases during customer site bring up

Qualifications

• Educational Requirements:
  • A bachelor's degree in engineering (e.g. Biomedical/Bioengineering, Mechanical, Electrical) with a minimum of 8 years of related work experience in medical device development
  • A master’s degree in engineering (e.g. Biomedical/Bioengineering, Mechanical, Electrical) with a minimum of 6 years of related work experience in medical device development
  • A PhD/MD with a minimum of 4 years of related work experience in medical device development
• Additional Qualifications:
  • An advanced degree (Masters, PhD, MD) is preferred
  • Experience collaborating with physicians to gather clinical performance feedback and identify unmet needs is required
  • Strong communication and interpersonal skills, with the ability to effectively collaborate with cross-functional teams such as R&D, product management, human factors, professional education etc. is required
  • Experience constructing customer and engineering design requirements is required
  • Experience designing and conducting pre-clinical engineering studies to assess product performance and safety is required
  • Proficient in identifying potential clinical risks and conducting thorough clinical harm analyses to enhance patient safety and product reliability is required
  • Experience developing Design Validation strategy, protocol creation and testing is required
  • Ability to draw conclusions and make recommendations based on technical and clinical inputs from multiple and varied sources is required
  • Outstanding problem-solving and analytical abilities, with a focus on identifying technical challenges and driving innovative solutions is required
  • Knowledge of endoscopic, laparoscopic procedures and operating room workflow is preferred
  • Familiarity with fundamental concepts in surgical robotics is an asset
  • Strong knowledge of relevant regulations and standards for medical devices and robotic surgery platforms, including FDA regulations and guidance, and IEC and ISO standards is preferred
  • Demonstrated success in leading and delivering complex projects from inception to completion is an asset
  • Travel willingness and ability to travel up to 15% of the time, internationally and domestically, is required

Education

• A bachelor's degree in engineering with 8+ years of related experience in medical device development; or
• A master’s degree in engineering with 6+ years of related experience; or
• A PhD/MD with 4+ years of related experience

Skills

• Required: Clinical Engineering, Design Validations, Voice of the Customer (VOC)
• Preferred: Bioinformatics, Biological Engineering, Biostatistics, Clinical Trials Operations, Coaching, Communication, Critical Thinking, Global Market, Healthcare Trends, Medical Affairs, Organizing, Product Development, Project Reporting, Research and Development, Researching, Resource Planning, SAP Product Lifecycle Management

Additional Requirements

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