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Research and Development Specialist
1 month ago
Location: Marlborough, MA
Duration: 8 months
Job SummaryWe are seeking a highly skilled Senior R&D Lab Technician to join our team at Integrated Resources. The successful candidate will have a strong background in medical device and life science industry, with experience in developing tests methods, writing test protocols, and verifying design specifications of new products.
Key Responsibilities- Perform and help develop hands-on tests of new products in development, including developing tooling and fixtures, and recording test data in accordance with cGxP.
- Prepare samples for test and evaluation, using testing frameworks that include both 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, and serve as a resource to the R&D Team.
- Collaborate with colleagues as necessary to gain access and training, and 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, and interface with external groups such as client factories and suppliers to ensure design transfer activities and to manage logistics for lab supply and sample.
- 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, and product reliability tests.
- Familiarity with assembly methods, especially those relevant to single-use biomedical products.
- 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).
Integrated Resources offers a competitive salary and benefits package, as well as opportunities for professional growth and development.
