Clinical Engineer: Revolutionizing Medical Robotics

3 weeks ago

Sunnyvale, California, United States Noah Medical Full time

About the Role:

Noah Medical is seeking a talented Clinical Engineer to join our team and contribute to the development of innovative medical robotics solutions. As a Clinical Engineer, you will play a key role in translating user needs into actionable plans, partnering with the Product Manager and engaging with physicians to design and run studies to assess the design's adequacy during development.

Responsibilities:

  • Develop internal expertise in clinical domains relevant to the company's products
  • Understand current state of end-user and patient environment
  • Build knowledge about relevant anatomy and disease states
  • Remain current with the latest in scientific publications relevant to the company's products
  • Attend key scientific conferences and engage with clinicians
  • Lead and execute evaluation of new product and service prototypes
  • Provide clinical perspective on product concepts
  • Perform bench assessments of prototype clinical performance
  • Understand clinical needs identified by development team
  • Understand and champion clinical value propositions defined by development team
  • Develop new test methods, models, and metrics for quantifying product performance
  • Own and manage in-house preclinical testing facilities
  • Manage regulatory compliance processes for the preclinical testing facilities
  • Lead development and execution of new protocols for assessing product characteristics in various tissue-based models
  • Own and deliver specific Clinical Engineering team deliverables throughout the project's lifecycle
  • Develop clinical hazards analysis and documentation to inform product design
  • Document existing procedure workflow and develop new product workflows throughout development process
  • Provide input to development teams to define and validate clinical performance goals for products
  • Develop customer training materials, user manuals, labeling, and other supporting materials
  • Assist in development of plans and materials for company engagement with the FDA and other regulatory bodies
  • Write plans, protocols, conduct formal testing, and report results of preclinical, formative, summative, and validation studies throughout the design process
  • Support initial product launch by developing customer training activities, supporting initial cases during customer site bring up, and conducting Physician Preference Testing

Requirements:

  • Experience in a medical devices industry
  • Bachelor's degree in Engineering or Science; Master's degree preferred
  • Strong technical experience and aptitude
  • Ability to effectively communicate concepts, ideas, and knowledge to other individuals and teams
  • Knowledge of basic anatomy, clinical terminology, and general surgical techniques
  • Knowledge of fundamentals of robotics or electromechanical systems
  • Experience in gathering customer feedback, generating user requirements, and conducting validation studies on medical devices
  • Experience in the regulated medical device environment, including but not limited to document control processes, design control processes, protocol development, and report writing
  • Experience working with healthcare providers in a hospital environment
  • Experience conducting Design Validation and Human Factors / Usability testing for FDA submissions
  • Ability to travel domestically up to 25% of the time

About Noah Medical:

Noah Medical is an innovative medical robotics company dedicated to transforming the healthcare landscape. Our team of experts is passionate about developing cutting-edge solutions that improve patient outcomes and enhance the lives of those affected by medical conditions.

What We Offer:

  • Competitive salary
  • Comprehensive health insurance including Medical, Dental and Vision + HSA and FSA options
  • Equity & Bonus Program
  • Life Insurance (company paid & supplemental) and Disability insurance
  • Mental health support through medical insurance programs
  • Legal and Pet Insurance
  • 12+ paid holidays, 15-20 days of PTO + use-what-you-need sick days
  • Paid parental leave
  • In-office snacks and beverages
  • In-office lunch stipend

Join Our Team:

Noah Medical is an Equal Opportunity Employer. We celebrate diversity and are committed to ensuring an inclusive environment for our employees. If you are a motivated and talented individual who is passionate about transforming the healthcare landscape, we encourage you to apply for this exciting opportunity.

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