Research And Development Technician

1 week ago

Marlborough, United States Integrated Resources, Inc ( IRI ) Full time

Title: Senior R&D Lab Technician


Location: Marlborough, MA


Duration: 8 months



Note: 7 plus years of experience required.



Top 3 skills:

  • Perform and help develop hands-on tests of new products in development. This could include developing tooling and fixtures. Record test data in accordance with cGxP.
  • Prepare samples for test and evaluation. Testing frameworks will include both development and verification/validation phase.
  • Contribute to the generation of work instructions, tests protocols, and reports.



Job Description:

  • Participate in the design and organization of experiments in conjunction with the Tech Lead and/or R&D Team members. Serve as a resource to R&D Team.
  • Collaborate with colleagues as necessary to gain access and training.
  • Follow departmental work instructions, SOP’s, OSHA safety regulations and cGxPs to perform assigned tasks.
  • Monitor and oversee lab supply inventory, generate expense purchase requisitions, if applicable, and maintain documentation in accordance with established procedures.
  • Interface with internal groups to assure laboratory equipment maintenance, calibration and documents conform with established practices.
  • Interface with external groups such as client factories and suppliers to ensure design transfer activities and to manage logistics for lab supply and sample.


Qualification:

  • Associate degree in technology or engineering or equivalent combination of education and work experience.
  • 8-10 years relevant work experience in medical device and/or life science industry (FDA 21CFR820, ISO13485).
  • Deep knowledge in medical device disposables (minimum Class II), with relevant experience in developing tests methods, writing test protocols, and verifying design specifications of new products.
  • Experience in manufacturing process development related to medical devices or life science disposable assets (IQ, OQ, PQ, Process FMEA).
  • Basic knowledge of mechanical design of fixtures (CAD Design - SolidWorks).
  • Familiarity with the mechanical testing of plastic parts and sub-assemblies (e.g., pull test, tensile/shear/compression test, integrity/leak testing (vacuum/pressure decay), burst test) and product reliability tests (e.g., ship testing, tear/wear/aging/stability tests).
  • Familiarity with assembly methods, especially those relevant to single-use biomedical products: mechanical fastening, heat sealing, UV-cure adhesive, part trimming/cutting, packaging, etc.
  • Familiarity with working in a cleanroom, laminar flow hood, or the like.
  • Background in metrology an asset.
  • Ability to work under cGxP guidelines.
  • Possess good computer skills (Microsoft Office is required as Word, Excel, Minitab).

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