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Mechanical Engineer

Nevro LLC

Position Summary At Globus Medical, we move with a sense of urgency to deliver innovations that improve the quality of life of patients with musculoskeletal disorders. Our team is inspired by the needs of these patients, and the surgeons and healthcare providers who treat them. We embrace a culture of exceptional response by partnering with researchers and educators to transform clinical insights into tangible solutions. Our solutions improve the techniques and outcomes of surgery so patients can resume their lives as quickly as possible. The Mechanical Engineer will design, develop, and deliver high‑reliability mechanical components and assemblies for ClassIII implantable neuromodulation systems and associated external accessories used in deep brain stimulation (DBS). This role ensures mechanical integrity, patient safety, and compliance with medical device regulations across the full product lifecycle. The engineer will also serve as a technical influencer, shaping mechanical architecture decisions, directing cross‑functional design activities, and guiding teams toward robust, scalable engineering solutions. Essential Functions Mechanical Design & Development Design mechanical components, assemblies, prototypes, and test fixtures for implantable devices and external system components. Establish and maintain mechanical requirements, specifications, and system‑level constraints. Conduct solid modeling, tolerance stack analysis, and GD&T‑based mechanical design. Interface with external vendors to develop prototypes, assess manufacturability, and optimize fabrication approaches. Develop and execute mechanical experiments, including test method definition, test setup design, and data analysis. Investigate mechanical failure modes and drive design changes through structured problem solving. Regulated Product Development Support Support development activities in compliance with FDA regulations and ISO standards for ClassIII implantable medical devices. Prepare, process, and maintain engineering documentation such as ECOs, reports, and design files. Contribute to verification and validation strategy and execution for mechanical subsystems. Ensure mechanical design decisions meet safety, reliability, and regulatory expectations across the development lifecycle. Technical Leadership & Influence Lead cross‑functional project team(s) to deliver mechanical solutions aligned with program goals. Influence product architecture, system‑level trade‑offs, material selection, and manufacturing strategies. Anticipate mechanical risks and proactively guide mitigation plans. Collaborate closely with systems, electrical, firmware, manufacturing, quality, and regulatory teams to ensure seamless system integration. Communicate effectively with physicians and clinicians to gather user insights and integrate feedback into design decisions. Innovation & Technology Development Evaluate new materials, manufacturing processes, and design methodologies to support feasibility and concept development. Support laboratory and clinical research activities by developing prototypes, fixtures, and investigational designs. Contribute to early‑stage concept development and participate in intellectual property generation. Quality & Process Discipline Follow quality system procedures, documentation practices, and laboratory standards. Support risk management documentation, including hazard analysis and failure modes and effect analysis (FMEA), to identify and mitigate design and process risks. Drive continuous improvement in mechanical design processes, test methods, and development workflows. Ensure all mechanical deliverables meet performance, reliability, and compliance requirements. Qualification Requirements Bachelor's degree and 3–5 years of related experience in medical device development or verification, preferably for ClassIII devices. Experience in a regulated industry; medical device experience strongly preferred. Self‑directed and able to determine and pursue courses of action to achieve desired results. Strong analytical and problem‑solving skills. Expertise in tolerance stack analysis, solid modeling, and GD&T. Experience with FEA, fatigue testing, and biomedical materials (preferred). Knowledge of plastic injection molding, welding, and other manufacturing methods for implantable devices. Experience designing implantable devices and surgical tools, including lead design, polymer cast headers, feedthroughs, and hermetic sealing. Experience with usability studies and translating clinical feedback from cadaver studies into design requirements. Strong communication and presentation skills with the ability to influence cross‑functional decisions. Ability to thrive in a fast‑paced, multidisciplinary environment. Willingness to travel approximately 10% of the time domestically and internationally. Physical Demands Required to sit; climb or balance; and stoop, kneel, crouch or crawl. Required to regularly lift and/or move up to 10 pounds, and occasionally lift and/or move up to 25 pounds. Required to possess specific visons abilities, including: close vision, distance vision, color vision, peripheral vision, depth perception and capacity to adjust focus. Equal Employment Opportunity Globus Medical is an equal opportunity employer. All applicants will receive consideration for employment without regard to race, color, religion, gender, sexual orientation, age, disability, marital status, pregnancy, national origin or citizenship. We are committed to a diverse workforce. We value all employees’ talents and support an environment that is inclusive and respectful. Reasonable Accommodations Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions. #J-18808-Ljbffr Nevro LLC

Vacancy posted 5 days ago
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