Future Opportunities: Clinical Engineering Team
May 7
🏢 In-office - Bay Area
Description
• 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.
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
Benefits
• 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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