Senior R&D Lab Technician

17 hours ago


Marlborough, Massachusetts, United States TalentBurst Full time
Job Title: Senior R&D Lab Technician

We are seeking a highly skilled Senior R&D Lab Technician to join our team at TalentBurst. This is a senior-level position that requires a strong background in medical device and life science industry.

Key Responsibilities:
  • Develop and perform hands-on tests of new products in development, including developing tooling and fixtures.
  • Record test data in accordance with cGxP guidelines.
  • Prepare samples for test and evaluation, including testing frameworks for development and verification/validation phase.
  • Contribute to the generation of work instructions, test protocols, and reports.
  • Participate in the design and organization of experiments in conjunction with the Tech Lead and/or R&D Team members.
  • Collaborate with colleagues as necessary to gain access and training.
  • Monitor and oversee lab supply inventory, generate expense purchase requisitions, 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 as Cytiva factories and suppliers to assure design transfer activities and to manage logistics for lab supply and samples.
Requirements:
  • 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, ISO).
  • 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 device or life science disposables an asset (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.
  • Strong communication, interpersonal skills, and the ability to work in a team environment are required.
  • Demonstrate strong ethical behavior.
  • Detail-oriented, and able to work independently as well as part of a team.
  • Possess good computer skills (Microsoft Office is required as Word, Excel, Minitab).


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