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- 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
- Develop clinical performance data to drive the characterization and development of new design iterations
- Lead and conduct pre-clinical testing experiments to validate system performance
- 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 design and implementation test methods, test metrics, and models that are clinically representative of the application's use
- Provide clinical perspective on model concepts
- Understand clinical needs identified by development team
- Perform bench assessments of prototype clinical performance
- Perform ex-vivo assessments of prototype clinical performance
- Design and develop new test models, and metrics for quantifying product performance.
- 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.
- 5 to 10 years of experience in a medical devices industry
- Bachelor's degree in Engineering or Science; Master's degree preferred
- Strong technical experience and aptitude
- Experience working with different type of anatomical and physiological models
- 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. (nice to have)
- Ability to travel domestically up to 25% of the time.
- 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
Staff Clinical Engineer - Sunnyvale, United States - Noah Medical
Description
About The Team
The Staff Clinical Engineer will work closely with cross-functional development teams to represent clinical value propositions for patients and providers throughout the design and development of new products. In addition, the Staff Clinical Engineer will be responsible for owning and delivering specific Product Development Plan (PDP) deliverables throughout the project's lifecycle.
A Day In The Life Of Our Staff Clinical Engineer
About You
Workplace Type: Hybrid
Benefits & Perks (For Full Time Employees):