US-CA-Redwood CityJob Post Information* : Posted Date
13 hours agoCategory
EngineeringMore information about this job:About Nevro
Nevro (NYSE: NVRO) is a public multinational medical technology company headquartered in Redwood City, California. We have developed HF10™ therapy, an innovative, evidence-based neuromodulation platform.
We started with a simple mission to help more patients suffering from chronic pain. At each stage of development, our research was subject to the highest levels of scientific rigor, resulting in a new therapy that has impacted the lives of over 28,000 patients around the world.
The Nevro® Senza® SCS System received CE mark in 2010, TGA approval in 2011, FDA approval in 2015, and is commercially available in Europe, Australia, and the United States.Overview This position plays a key role in the development of the next generation of Class III implantable Neuromodulation system for pain management. This is a technical position that reports to a Principal Engineer, Manager or higher organizational leader. Role Requirements
Skills and Knowledge
- Perform tasks required in medical device product development - for implanted devices as well as for external components and peripherals.
- Establish product requirements and specifications
- Designs medical device components and fixtures
- Interfaces with external vendors to develop prototypes
- Designs, runs, and gathers data for experiments
- Analyzes and documents test results in a laboratory notebook
- Participates in the design of new test methods and procedures
- Responsible for processing ECOs and other documentation in compliance with FDA guidelines and ISO requirements
- Supports laboratory and clinical research
- Prepares reports and presentations and documents progress with senior management
- Interface with other departments such as Marketing, Manufacturing, Regulatory and Quality
- Communicates with physicians and other clinicians on product design and development activities and gathers feedback on product prototypes
- Investigate and solve mechanical product failure modes and devise solutions to problems
- Understands and can operate within a highly regulated environment following industry technical and test standards as well as good documentation and laboratory practices.
- Performs other related duties as assigned
- Bachelor's Degree in Engineering (Mechanical, Aerospace or Biomedical) and a minimum of 2 years experience in regulated industry. Prior medical device experience preferred. Graduate degree is a plus.
- Good analytical and problem solving skills
- Ingenuity and ability to innovate clever solutions to problems
- Strong theoretical knowledge in areas such as tolerance stack-up, solid modeling and design, GD&T
- Experience in FEA, fatigue testing, and biomedical materials are desirable
- Experience with manufacturing techniques such as plastic injection molding and joining techniques such as welding is desirable
- Excellent oral and written communication along with good presentation and technical writing skills
- Knowledge of medical device quality assurance is a plus
- Ability to thrive in a fast-paced, multidisciplinary environment
- Requires the ability to travel approximately 10% of the time throughout the United States and internationally
Nevro offers equal employment opportunity, regardless of race, color, creed, religion, national origin, marital or family status, sex, sexual orientation, gender expression (including religious dress and grooming practices), gender (including pregnancy, childbirth or medical condition related to pregnancy or childbirth), physical or mental condition, disability, age or other characteristics protected by laws.