Clinical Engineer

1 month ago

Sunnyvale, United States Noah Medical Full time

About The Team:

The Clinical Engineering Team at Noah Medical is dedicated to ensuring the products Noah is developing meet all of the clinical and user needs. We collaborate closely with our end users (physicians) to understand their needs and the clinical value Noah's products will bring them. The Clinical Engineering team also works closely with cross-functional development teams to represent clinical value propositions for patients and providers throughout the design and development of new products. Join us to contribute to Noah Medical's growth and to shape the future of medical robotics.

A Day In The Life Of Our Clinical Engineer:

* 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
* Become aware of alternative and competing treatment modalities, 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 the evaluation of product concepts, prototypes, and clinical performance
* Understand clinical needs and provide clinical perspective on product concepts
* Understand and champion clinical value propositions defined by development team
* Develop new test methods, models, and metrics for quantifying product performance. Lead development and execution of new protocols for assessing clinical performance in various tissue-based models.
* Perform system level application testing of clinical performance
* Analyze customer feedback to understand how to incorporate it into tangible product improvements
* Analyze test results meticulously, drawing meaningful conclusions regarding the clinical performance of the medical device under various conditions.
* Provide clear and concise reports, summarizing findings, trends, and potential areas for improvement to support data-driven decision-making.
* Own and deliver specific Clinical Engineering team deliverables throughout the project's lifecycle
* Develop clinical hazards analysis, risk analysis and documentation to inform product design
* Document existing procedure workflow and develop new product workflows throughout development process
* Write plans, protocols, conduct formal testing, and report results of preclinical, formative, summative, and validation studies throughout the design process
* Assist in development of plans and materials for company engagement with the FDA and other regulatory bodies.

About You:

* 0 to 5 years of 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.
* Motivated and driven individual who can take initiative on new projects
* Ability to travel domestically up to 25% of the time.

Workplace Type: Hybrid

Benefits & Perks (For Full Time Employees):

* 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
* Learning & Development Opportunities: On-demand online training and book reimbursement
* Team building and company organized social and celebration events

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