Senior Device Mechanical Engineer at New Deantronics

Sparks, Nevada, United States -

Full Time

Start Date

Immediate

Expiry Date

04 Mar, 26

Salary

0.0

Posted On

04 Dec, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Mechanical Design, Medical Device R&D, Leadership, Project Management, CAD Software, Manufacturing Processes, Prototyping, Regulatory Compliance, Problem-Solving, Team Collaboration, Risk Assessment, FMEAs, Technical Documentation, Root Cause Analysis, Continuous Improvement, Design Verification

Industry

Medical Equipment Manufacturing

Description

Description 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 What You'll Do 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. Requirements What We're Looking For 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. Desired Skills and Attributes 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. Familiarity with medical device regulations (FDA, ISO 13485) is required.

Responsibilities

The Senior Device Mechanical Engineer will lead engineering teams in the design and development of medical devices and small fixtures, ensuring compliance with regulatory standards. This role involves managing complex projects from concept through production while driving continuous improvement initiatives.