Section Leader Manufacturing Engineer

Operations              ·                  CR-Alajuela                 ·            Full time

Section Leader Manufacturing Engineer

Job Location: CR-Alajuela

Job Post Information

Posted Date:  January 10, 2024 12:35 AM

ID: 2023-4350

Category: Operations

About Nevro

Nevro (NYSE: NVRO) is a global medical device company headquartered in Redwood City, California. We are focused on delivering comprehensive, life-changing solutions that continue to set the standard for enduring patient outcomes in chronic pain treatment. The company started with a simple mission to help more patients suffering from debilitating pain and developed its proprietary 10 kHz Therapy, an evidence-based, non-pharmacologic innovation that has impacted the lives of more than 100,000 patients globally.  

Nevro’s comprehensive HFX™ spinal cord stimulation (SCS) platform includes a Senza SCS system and support services for the treatment of chronic trunk and limb pain and painful diabetic neuropathy.  Senza®, Senza II®, Senza Omnia™, and Senza HFX iQ™ are the only SCS systems that deliver Nevro’s proprietary 10 kHz Therapy. HFX iQ, Nevro’s latest innovation, is the first and only SCS System that uses Artificial Intelligence to optimize and maintain pain relief using each patient’s response1.Nevro’s unique support services provide every patient with an HFX Coach™ throughout their pain relief journey and every physician with HFX Cloud™ insights for enhanced patient and practice management. 

Nevro also recently added a minimally invasive treatment option for patients suffering from chronic sacroiliac joint (“SI joint”) pain and now provides the most comprehensive portfolio of products in the SI joint fusion space, designed to meet the preferences of physicians and varying patient needs in order to improve outcomes and quality of life for patients.

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 Site Director of Costa Rica.  This position will be located in the Coyol FTZ Park in Costa Rica.

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
• Other duties as assigned. 

Role Requirements

• B.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.

EEO Statement

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, protected veteran status, disability, age or other characteristics protected by laws.

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