Leads mechanical and opto-mechanical development of complex light-based medical devices from design inputs through verification, validation, and manufacturing transfer. Develops specifications, intellectual property, cost-reduction initiatives, prototypes, optical systems, thermal-management solutions, and regulatory documentation. Coordinates internal teams, suppliers, partners, and customer transfers while ensuring compliance with FDA requirements, ISO 13485, and CE Mark standards. Requires advanced mechanical engineering expertise, SolidWorks proficiency, project leadership, and occasional travel.
Job Summary & Responsibilities Pay Range
Senior Opto-Mechanical EngineerII-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 (<20%)
* 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).
* 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 requirements
- MS in Mechanical Engineering or related field
- 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.
MA: $93,039 - $123,277
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