Section Leader Manufacturing Engineer

hace 2 semanas

Alajuela, Costa Rica Nevro A tiempo completo

Job Summary

& Responsibilities

Nevro is seeking a Section Leader 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 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 evaluations

Skills and Knowledge

Role Requirements

S. Mechanical/Electrical Engineering. Advanced degree (M.S.) is preferred. A minimum of 8 years of experience within the Medical Device industry, preferably manufacturing and/or designing Active Implantable Medical Devices (AIMDs) preferred.

Skills and Knowledge

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.

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