Senior Clinical Engineer - NOAH MEDICAL : Job Details

Who We Are Noah Medical is building the future of medical robotics. Our next generation robotic platform targets early diagnosis and treatment of patients across multiple disease states. Based in Silicon Valley and backed by well-known institutional investors, our incredibly talented team of engineers, innovators and industry leaders brings years of experience from the top healthcare companies in the world, including: Intuitive, Auris, Stryker, Johnson & Johnson, Boston Scientific, Verb Surgical, Mako, Think Surgical, Medrobotics & Hansen. The Senior 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 Senior 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 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.

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 Noah Medical may offer remote, hybrid, or onsite work arrangements within the state of California depending on the specific team and/or role where applicable. Noah Medical is an Equal Opportunity Employer. We celebrate diversity and are committed to ensuring an inclusive environment for our employees. Applicants are considered for all positions without regard to race, color, religion, sex or gender, gender identity or expression, sexual orientation, national origin, ancestry, age, genetic information, physical or mental disability, marital or protected military or veteran status, or any other consideration made unlawful by federal, state or local laws. Please visit our Careers Page to view our latest openings.