Senior Clinical Engineer

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.