Auris Health Inc., part of the Johnson & Johnson family of companies, is recruiting for Senior Clinical Engineer, located in Redwood City, CA.
Auris Health, Inc., part of the Johnson & Johnson family of companies, is transforming medical intervention. By combining advancements in medical robotics, instrumentation, navigation and data science, Auris is building a platform technology capable of expanding the applicability of robotics to a spectrum of medical procedures. Learn more about Auris Health at https://www.aurishealth.com/.
As a member of the Clinical Innovation team, the Senior Clinical Engineer will work closely with cross-functional development teams to champion clinical value propositions for patients and providers throughout the design and development of new products. This individual will be responsible for leading development activities to inform design and development, and will be responsible for leading and executing Design and Development Plan (DDP) deliverables throughout a project’s lifecycle.
Your primary responsibilities will include, but are not limited to:
• Lead collaborations with development teams to define and validate clinical performance goals for products
o Lead evaluation of new product and service prototypes
o Contribute to a strategic vision and provide clinical perspective on product concepts
o Conduct informal assessments of prototype clinical performance
o Analyze user feedback and provide clinical input to engineering team to ensure product meets clinical user needs
o Establish models and experimental techniques to evaluate product performance and value propositions
o Work with product management to identify unmet clinical needs and define new solution embodiments
• Cultivate knowledge in clinical arenas related to Auris’s products
o Understand current state of end-user and patient environment
o Continually refresh knowledge about relevant anatomy and disease states
o Keep up-to-date view of alternative and competing treatment modalities
o Attend key scientific conferences and regularly engage clinicians
o Serve as a liaison between clinicians and design teams
• Champion specific Clinical Engineering team deliverables throughout design and development
o Drive user-centric product vision to ensure successful integration with existing clinical workflows in a real-world environment
o Assess clinical hazards and document to inform product design
o Write protocols, conduct formal testing, and report results of human factors formative, summative, validation and other studies throughout design process
o Assist in the preparation of regulatory filings
• Support clinical evaluation and commercial use of company’s products
o Manage product evaluations at clinical sites
o Capture feedback and insight about clinical needs about company and competitive products being used in the market
• This position operates in a professional office environment.
• This role routinely uses standard office equipment such as computers, phones, and photocopiers.
• While performing the duties of this job, the employee is regularly required to talk or hear.
• The employee frequently is required to stand, walk; use hands to finger, handle or feel; and reach with hands and arms.
• This is a full-time position. Days and hours of work are flexible Monday through Friday, generally 8:30 a.m. to 5:30 p.m. Occasional evening and weekend work may be required as job duties demand
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
• 3 years’ experience in medical technology company
• Bachelor’s degree in Engineering or Science
• Experience with a complex medical device in a pre-clinical setting
• Must have a demonstrated ability to effectively and clearly communicate concepts, ideas and knowledge to other individuals and teams
• Must have strong analytical and problem-solving skills, as well as a good background in the product development process
• Experience working with cross-functional teams across multiple engineering disciplines, including mechanical, software, electrical, and visual/industrial design
• Experience in the regulated medical device environment, including but not limited to document control processes, document approval processes, study archiving, data collection and phase/design reviews
• Ability to travel up to 30% of the time, internationally and domestic
• Ability to work in a regulated environment in compliance to ISO 13485 and 21 CFR 820.
• Advanced Degree
• Experience in conducting design validation studies and gathering physician feedback on medical devices
• Knowledge of basic anatomy, clinical terminology and general surgical techniques
United States-California-Redwood City-
Auris Health, Inc. (6267)