Engineer

Spectraforce Technologies
United States, California, Irvine
Feb 14, 2025
Job Title: Engineer Duration: 12 Months Location: Irvine CA ( 92612) We are looking for a PDS&T Test Engineer II to join our PDS&T Combination Products, Aesthetics and Devices (CAD) organization in Irvine, CA. This individual will contribute to the development and launch of exciting new drug/device combination products, with a focus on Eye Care and Aesthetics. The Engineer conceives and implements novel testing approaches to Design V&V. He/she investigates, identifies, develops, and optimizes new test methods and techniques, as a critical contributor to feasibility, development, and verification stages of product development through creation and release of design verification plans, protocols, records and reports, while developing productive collaborations and communications with other groups across engineering disciplines Routinely demonstrate test engineering initiative and creativity in the V&V activities. Highly autonomous and productive in performing experimental research or test method development, requiring only minimal direction from or interaction with supervisor. Formulate conclusions and design follow-on tests as needed based on multidisciplinary data. Be a primary author of developing test protocols and reports. Demonstrates high proficiency across a wide range of relevant technologies, in his/her projects as well as the overall program, while maintaining a high level of productivity in the lab. Understand and adhere to corporate standards regarding code of conduct, safety, appropriate handling of materials, GLP/GMP compliance, etc Education and Experience A degree in an engineering field (mechanical, materials, chemical, bioengineering): BS or MS education and extensive, typically 3-5 years of experience. Possess thorough theoretical and practical knowledge to carry out lab testing and other lab-based activities. General understanding of the safety requirements for the lab-based activities. Adept experience with tooling and test fixture design using SolidWorks and 3D printing. Experience with work in the regulated environment desired, developing test tools and test methods conforming to regulated industry standards. Demonstrated experience of good documentation practice (GDP) and good laboratory practice (GLP) essential. Essential Skills and Abilities V&V testing experience Test method development/validation Good communication and interpersonal skills, both written and oral. Ability to develop and execute design verification and validation plans, protocols, data processing, and test reports. Proficiency in MS Office, Minitab, Visio, MATLAB, LabView. Fixture design - CAD/SolidWorks, execution, test. A team attitude with positive outlook is a must.