Senior Mechanical Engineer - Medical Devices

Position

The Senior Mechanical Engineer will lead development of complex medical devices and subsystems through all development phases from design input through verification and validation to manufacturing transfer stages, and in coordination with overall system requirements.

Responsibilities

• Assist in developing an IP portfolio for these instruments and provide original technical solutions to improve performance, functionality, reliability, and cost requirements.
• Develop product specification in coordination with marketing, customers, and other company departments.
• Coordinate the technical part of the transfer of company products and instruments to customers or distributors, including analysis of customer complaints and recommendations.
• Provide a cost reduction program for medical instruments.
• Ensure product designs meet stringent global regulatory requirements for medical devices, including FDA regulations, ISO 13485, the CE mark for medical devices, and other requirements.
• Assist in the development and maintenance of the design history file and other documentation to support product regulatory approval and manufacture.
• Requires some travel to interface with the domestic partner and regional facilities (<10%).

Requirements

• Education: BS in Mechanical Engineering, MS in Mechanical Engineering preferred.
• Knowledge: Strong knowledge of the engineering aspects of US and global regulatory requirements for medical devices.
• Experience: Experience in research and development, designing light-based medical instrumentation and products.
• Experience: 10 years of Mechanical Design Engineering within the Medical Device Industry.
• Experience: 5 years of Mechanical Design Engineering experience in Laser, Optical, within the Medical Device Industry.
• Experience: 5+ years in a senior position of supervising the technical part of development projects with internal and external teams, development partners, and suppliers within a company operated under ISO 13485 and FDA protocol in all phases from design input to transfer to production.
• Skills: Strong project management & leadership skills and experience.
• Experience: Experience with a 3D design tool, preferably SOLIDWORKS, including PDM systems.
• Experience: Extensive experience in the development of optical systems, including alignment, stability, packaging, tolerancing, and specifying optical components.
• Success: Demonstrated success in directing, coordinating, and executing all phases, including planning, organization, execution, integration, and completion of engineering projects.
• Knowledge: Knowledge of optical materials, coatings, and drawing practices.
• Experience: Experience with thermal management of optical systems, including source cooling with air, fluid, TEC’s, etc.
• Knowledge: Strong working knowledge of device packaging, opto-mechanical, interfacing with systems and electronics groups, & automation systems.
• Experience: Experienced SolidWorks user.
• Approach: Innovative approach in the development of multi-functional medical instruments, including mechanical/optical/electronic components and lab experimentation with breadboards.
• Coordination: Coordination of development teams, working within strict time schedules and budget boundaries, managing multiple suppliers and development partners, negotiating specifications and technical terms of the projects.
• Success: Successful records of rapid prototyping for pre-clinical and clinical studies.
• Experience: Experienced SolidWorks user.
• Knowledge: Apply knowledge of engineering principles to design components and mechanisms. Experience with MS Office products (Word, Excel, PowerPoint, Project, and Visio).