Senior Lab Technician

Job Summary: The Senior Lab Technician plays a crucial role in supporting the R&D team by participating in the design and execution of experiments and testing new products in development. This role involves hands-on testing, generating reports, and contributing to the development of testing frameworks. The Senior Lab Technician ensures lab equipment maintenance and compliance with safety regulations and interfaces with both internal and external groups to facilitate lab operations and logistics. Key Responsibilities: Participate in designing and organizing experiments in collaboration with the Tech Lead and R&D team members. Perform hands-on tests of new products, including developing tooling and fixtures, and record test data in accordance with cGxP guidelines. Prepare samples for test and evaluation in both development and verification/validation phases. Collaborate with colleagues to access necessary resources and training. Generate work instructions, test protocols, and reports. Follow departmental SOPs, OSHA safety regulations, and cGxP guidelines. Monitor lab supply inventory and manage procurement and documentation as needed. Ensure laboratory equipment maintenance, calibration, and documentation compliance. Interface with Cytiva factories, suppliers, and other external groups to manage design transfer activities and logistics. Required Qualifications: Associate Degree in Technology or Engineering, or equivalent education and experience. 8-10 years of relevant work experience in the medical device or life sciences industry (FDA 21CFR820, ISO13485). Deep knowledge of medical device disposables (minimum Class II) with experience in developing test methods, writing test protocols, and verifying design specifications. Experience in manufacturing process development for medical devices or life sciences disposables (IQ, OQ, PQ, Process FMEA). Basic knowledge of mechanical design and CAD design (SolidWorks). Familiarity with mechanical testing (pull tests, tensile/shear/compression tests) and product reliability tests (ship testing, aging, stability tests). Experience with assembly methods relevant to biomedical products, including mechanical fastening, heat sealing, UV-cure adhesive, and packaging. Familiarity with cleanroom environments and working under cGxP guidelines. Proficient in Microsoft Office (Word, Excel, Minitab). Preferred Qualifications: Background in metrology. Strong ethical behavior, detail-oriented, and able to work both independently and as part of a team. Excellent communication and interpersonal skills.

Created: 2024-11-05