Senior R&D Lab Technician - Sunrise Systems Inc
Marlborough, MA 01752
About the Job
Job Title: Senior R&D Lab Technician
Reference ID: 24-04657
Location: Marlborough, MA
Duration: 8 Months
Job Type: Contract (Candidates must be able to work on W2 without VISA sponsorship)
What you’ll do
Who you are
Reference ID: 24-04657
Location: Marlborough, MA
Duration: 8 Months
Job Type: Contract (Candidates must be able to work on W2 without VISA sponsorship)
What you’ll do
- 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.
- 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.
- Collaborate with colleagues as necessary to gain access and training.
- Contribute to the generation of work instructions, tests protocols, and reports.
- 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 and suppliers to assure design transfer activities and to manage logistics for lab supply and samples.
Who you are
- 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 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 behaviour.
- 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).
Source : Sunrise Systems Inc
