Senior Device Mechanical Engineer

New Deantronics-posted 18 days ago
Full-time • Senior
Sparks, NV
501-1,000 employees
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The Senior Device Mechanical Engineer will provide technical leadership and strategic direction in the design, development, and improvement of medical devices and related R&D projects. This role focuses on creating novel medical devices and small fixtures, ensuring designs are robust, manufacturable, and compliant with regulatory standards

  • Lead and mentor engineering teams in the design and development of medical devices and small fixtures, from concept through prototyping, testing, and transfer to manufacturing.
  • Serve as a technical expert and advisor to cross-functional teams including manufacturing, quality, R&D, and maintenance to ensure device designs are innovative, manufacturable, and meet user needs.
  • Oversee the development of detailed mechanical designs, including CAD models, drawings, and specifications, ensuring best practices in design for manufacturability and assembly.
  • Manage complex medical device projects from concept through design verification, validation, and transfer to production, ensuring timelines, budgets, and quality standards are met.
  • Drive troubleshooting, root cause analysis, and continuous improvement initiatives for existing device designs and fixtures.
  • Ensure compliance with applicable regulatory standards (e.g., FDA, ISO 13485) during design and development, and champion best practices in documentation and validation.
  • Lead risk assessments, FMEAs, and design reviews for medical devices and fixtures.
  • Manage relationships with external vendors and suppliers, including sourcing components and overseeing outsourced prototyping or manufacturing projects.
  • Prepare and review engineering documentation including design history files, validation protocols, and technical reports.
  • Bachelor's degree in Mechanical Engineering or related field.
  • 7+ years of experience in mechanical design, preferably in medical device R&D or a regulated industry, with demonstrated leadership in project or team settings.
  • Extensive experience with medical device design, prototyping, and small fixture development.
  • Advanced proficiency with CAD software (e.g., SolidWorks, Creo, Inventor).
  • In-depth knowledge of manufacturing processes such as machining, assembly, and molding.
  • Strong project management, leadership, and communication skills.
  • Familiarity with medical device regulations (FDA, ISO 13485) is required.
  • Expert knowledge of medical device design principles, including design for manufacturability, reliability, and regulatory compliance.
  • Proven ability to design mechanical systems and small fixtures for medical applications.
  • Advanced understanding of prototyping methods, materials selection, and manufacturing strategies.
  • Ability to interpret, create, and review engineering drawings, schematics, and technical documentation.
  • Exceptional analytical and problem-solving skills.
  • Ability to work independently, lead teams, and collaborate in a multidisciplinary environment.
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