A Day In The Life Of Our Senior 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 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.
About You
- 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
- 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.
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