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Senior Clinical Engineer - Sunnyvale, United States - Noah Medical
Description
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.
ADay 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.
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 conducting Design Validation and Human Factors / Usability testing for FDA submissions.
Ability to travel domestically up to 25% of the time.
Workplace Type:
Hybrid
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
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