Nevro (NYSE: NVRO) is a global medical device company headquartered in Redwood City, California. We are focused on providing innovative products that improve the quality of life of patients suffering from debilitating chronic pain.
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 70,000 patients around the world.
Nevro has developed and commercialized the Senza spinal cord stimulation (SCS) system, an evidence-based, non-pharmacologic neuromodulation platform for the treatment of chronic pain. HF10 therapy has demonstrated the ability to reduce or eliminate opioids in ≥65% of patients across six peer-reviewed clinical studies. The Senza® System, Senza II™ System, and the Senza® Omnia™ System are the only SCS systems that deliver Nevro's proprietary HF10® therapy.
Nevro is seeking a Senior Manufacturing Engineer that will play a key role in ensuring manufacturability and testability of product designs and ensure supply chain, manufacturing processes, tools and equipment are in place and capable of delivering Class III implantable Neuromodulation system for pain management. This position reports to the Senior Operations Engineering Manager.
- Proven experience in successfully leading Operations key initiatives (i.e. second sourcing, cost reductions) and/or NPI/design transfer of Class III implantable Neuromodulation system components to Contract Manufacturers.
- Lead and participate in DFx process of proposed designs and prototypes to evaluate suitability for production and improve manufacturability.
- Manage and maintain BOM (Bill of Materials), MP (manufacturing procedure) thru the change order process.
- Work with High Volume Contract Manufacturers and second tier suppliers to bring new products into production and/or resolve existing production/quality/yield issues.
- Lead the acquisition, installation and qualification of production equipment and tooling, including writing the IQ, OQ, PQ documentation.
- Work with High Volume Contract Manufacturers to evaluate production strategies and processes; design and layout production lines, methods, tools and tooling.
- Work with High Volume Contract Manufacturers and suppliers to optimize manufacture of outsourced assemblies, sub-assemblies and components.
- Working in accordance with Quality System procedures and actively enforces its objectives.
Participate inn supplier audits and evaluationsRole Requirements:
- S. Mechanical/Electrical Engineering. Advanced degree (M.S.) is preferred.
- A minimum of 5 years of experience within the Medical Device industry, preferably manufacturing and/or designing Active Implantable Medical Devices (AIMDs) preferred.
- Strong project leadership skills, utilizing structured project management tools.
- Strong interpersonal and technical writing skills.
- Experience managing high volume Contract Manufacturers (full turnkey).
- Strong electro-mechanical design/manufacturing and analysis skills.
- Experience with Solidworks a plus.
- Good analytical and problem solving skills.
- Functional familiarity with the FDA Submission process, ISO Requirements and QSR requirements is also preferred.
- Requires the ability to travel approximately 20% of the time throughout the United States and internationally.