Senior Mechanical Engineer - Medical Devices
Duties
- 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
- Assist in developing IP portfolio for these instruments and provide original technical solutions to improve performance, functionality, reliability costs requirements
- Develop product specification in coordination with marketing, customers and other company departments
- Coordinate technical part of transfer of company products and instruments to customers or distributors, including analysis of customer complaints and recommendations;
- Provide cost reduction program for medical instruments
- Assure products are designed to meet stringent global regulatory requirements of medical devices, such as FDA regulations, ISO 13485, CE mark for medical product and others
- Assist in development and maintaining of design history file and other documentation to support product regulatory approval and manufacture
- Requires some travel to interface with domestic partner and regional IPG facility (<10%)
- BSME, MSME preferred
- Minimum 10 years of Mechanical Design Engineering experience in Laser, Optical and Medical Device Industry
- Strong project management & leadership skills and experience
- Experience with a 3D design tool, preferably SOLIDWORKS including PDM system
- Strong working knowledge of device packaging, opto-mechanical, interfacing with systems and electronics groups, & automation systems as a plus
- Ability to direct, coordinate and execute all phases including planning, organization, execution, integration and completion of engineering projects
- Apply knowledge of engineering principles to design components and mechanisms
- Experience with MS Office products (Word, Excel, PowerPoint, Project and Visio)
Education requirement
- BS in Mechanical Engineering, MS in Mechanical Engineering preferred
- Strong knowledge of the engineering aspects of US and global regulatory requirements for medical devices
- Experienced SolidWorks user
Experience requirements
- 10+ years of work experience in research and development designing light based medical instrumentation and products, with more than 5 years in senior position of supervising 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
- Extensive experience in development of optical systems including alignment, stability, packaging, tolerancing, and specifying optical components. Knowledge of optical materials, coatings, drawing practices
- Experience with thermal management of optical systems including source cooling with air, fluid, TEC’s etc
- Innovative approach in development of multi-functional medical instruments including mechanical / optical / electronic components and lab experimentation with breadboards
- Coordination of development teams, work within strict time schedules and budget boundaries, managing multiple suppliers and development partners, negotiating specifications and technical terms of the projects
- Successful records of rapid prototyping for pre-clinical and clinical studies