Mechanical Engineer

3 months ago

Oak Ridge, United States Rbm Services Full time
Job DescriptionJob DescriptionSalary:

Company Description


Founded in 2000 locally owned and operated, RbM Services is a growing turn-key design, manufacture, and service solution provider for medical devices in Tennessee’s Technology Corridor.  With over 100 years of combined experience in the medical device industry, our management staff has extensive experience in intellectual property development, contract design, product development, field service support, and product support of medical devices and laboratory instrumentation. Our team is passionate and even obsessed with providing solutions that deliver cutting-edge technology that improves patient experiences and outcomes.  Our passion lies in the pursuit of perfection. We value our employee family and foster opportunities for us to engage in meaningful connections and we reward employees who exceed expectations.


Job Description


Participating with a cross-functional team on new-product transition from the design owner/legal Device Manufacturer to our Company. This includes obtaining the overall understanding, intended use, and theory of operation of the device, determining how the current Device Master Record documentation will be transitioned into Company’s quality management system and ERP system, and determining any potential gaps in Device Master Record documentation that should be addressed for our staff’s training, skills, and expertise related to manufacturing, testing, and servicing the specific technology.


  1. Creating of error free solid models.
  2. Supporting the implementation of the plans made for new-product transition.
  3. Identify specialized technologies inherent to products to be manufactured and gain technical understanding and confidence to be a technical reference on those products.
  4. Identify and develop test fixtures (including needed software) for subassembly verification prior to final system integration. Develop and validate final system test methodology and procedures.
  5. Implementing the Product Engineer’s strategy for training manufacturing, testing, and servicing employees on device changes.
  6. Provide technical support to staff in the field during service events.
  7. Source and validate alternate components to alleviate end of life components.
  8. Investigating actual product performance and reliability issues and developing appropriate mitigations.
  9. Reviewing the product for potential performance or reliability issues and developing preventive mitigations.
  10. Reviewing the product for potential improvements and design and implement those improvements.
  11. Reviewing suggested changes to the device. This includes reviewing the impact to the Design History File, device master record, compliance testing reports, regulatory submission documents, and risk management reports.
  12. Planning and performing necessary verification and validation for changes prior to implementation.
  13. Participating in the review of in-house non-conforming product, determining how to disposition the issue, and discussing with a cross-functional team what mitigations could be implemented for the prevention of future occurrences, and determine if the risk/benefit analysis supports the implementation of the potential mitigations.
  14. Complete other duties as assigned


Required Qualifications

 

  • Degree in Mechatronics or Mechanical Engineering.
  • 7 + Years’ Experience in an Engineering Role in a Manufacturing Industry, ideally in a regulated industry like medical devices.
  • Mastery of SolidWorks and its capabilities.
  • Experience with multiple types of manufacturing technologies (CNC, injection molding, sheet metal, machining, casting, etc.).
  • Ability to create solutions within the confines of design constraints.
  • Ability to design automated test fixtures.
  • Ability to read standards that apply to specific products and apply the requirements to the product design.
  • Microsoft Office Suite Proficient.
  • Manage multiple assignments simultaneously



Additional Information


  • Relocation assistance eligible.
  • As a full-time team employee, you are eligible for all RbM Services benefits including medical, dental, vision, long-term, short-term disability, 401k, PTO, 10 paid holidays, etc.
  • All your information will be kept confidential according to the EEO guidelines.


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