Sr. Manufacturing Supplier Engineer

Nevro is seeking a Sr. 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 Sr. Principal Manufacturing Engineer or equivalent. This position will be located in the Coyol FTZ Park in Costa Rica.

• Responsible for overseeing and managing the manufacturing engineering activities such as planning, designing, testing, implementing, and improving the methods, equipment, tools, and systems that are used to produce, assemble, and package the products.
• Evaluation of production equipment to support process improvements, capacity and cycle time requirements.

• Lead the acquisition, installation and qualification of production equipment and tooling, including writing the IQ, OQ, PQ documentation.

• Coordinates with other engineers, technicians, managers, suppliers, and customers to ensure that the production processes meet the quality, safety, cost, and delivery standards and requirements.
• Understand manufacturing and problem-solving concepts like Value Stream mapping, 5S and DMAIC to improve quality, labor efficiency, and throughput.

• Lead, participate and proposed suitability solutions for production and improve manufacturability.
• Manage and maintain MP (manufacturing procedure) through the change order process.

• Drive regular production meetings to monitor manufacturing line performance metrics/line health (First pass yield, Scrap Rate, NC rate).
• Utilize tools such Gage R&R, Cp, Cpk, and SPC to ensure capable processes and improve process and first pass yield and eliminate scrap.
• Make sure that manufacturer’s procedures and instructions are followed in order to keep production process and equipment operational.
• Analyze production processes, schedules, methods and other data and then provide management with reports containing the data and statistics to enable management to better understand future requirements needed for the manufacturing process.

Work with Quality counterpart to address manufacturing nonconformances and customer complaint

• S. Mechanical/Electrical Engineering. Advanced degree (M.S.) is preferred.
• A minimum of 6-8 years of experience within the Medical Device industry, preferably manufacturing and/or designing Active Implantable Medical Devices (AIMDs) preferred.
• Strong troubleshooting skills; Proficiency in Electronic hardware, including data acquisition, oscilloscope, etc. Ability to read technical drawings, schematics, and BOMs.

• Adhere to all EHS rules and requirements and take adequate control measures in preventing injuries to themselves and others as well as to the protection of the environment and prevention of pollution under their span of influence/control.

• Must be organized, detail-oriented and adaptable.
• Strong English oral and written communication.

• Knowledge of ISO 13485, Current US Food and Drug Administration -Quality System Regulations.

• Strong project leadership skills, utilizing structured project management tools.
• Strong interpersonal and technical writing skills.
• Experience managing component suppliers.
• Prior experience with manufacturing transfers
• Strong electro-mechanical design/manufacturing and analysis skills.
• Experience with Solidworks and Six Sigma Certification a plus.
• Good analytical and problem-solving skills.
• Strong technical, analytical, problem-solving, communication, decision-making, and project management skills.
• Familiar with various manufacturing technologies, such as CAD/CAM, CNC, PLC, robotics, automation, lean manufacturing, and Six Sigma
• Requires the ability to travel approximately 20% of the time throughout the United States and internationally.
• Adhere to all EHS rules and requirements and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control.
• Must be organized, detail-oriented and adaptable.