Senior Device Mechanical Engineer

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.