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Open nowPosted 238 days ago

Senior Mechanical Engineer

IPG Photonics73 open roles

Where
Marlborough, MA, USA
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Your applicationOpen nowSenior Mechanical EngineerIPG Photonics · Marlborough, MA, USA

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Share of postings closed within
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  2. 4.3%3 days
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  4. 18.1%14 days
  5. 35.6%30 days
  6. 44.6%60 days
This job: posted 238 days ago

The posting

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).

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.
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