Research And Development Technician

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).