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- Prior experience as a sustaining engineer (R&D) in a medically regulated industry (Class II or III highly preferred)
- Design verification and validation experience in the medical device industry
- Basic understanding of Solidworks CAD system
- Exposure to failure mode analysis.
- PPK, MLTL, or any base level knowledge of statistical tools or analysis (Minitab use).
- Works independently without close supervision
- Compares and evaluates possible courses of action after considering various possibilities
- Applies his or her knowledge in following procedures or in determining which procedures to follow ordetermining whether specified standards are met
- Considers the cause and effect of activities exhaustive, and which allow room for creativity and judgment
- Direction tends to be high level and focused on end results with means of accomplishment left toincumbentEducation & Experience Required-Bachelor's degree in engineering required.
R&D Engineer, Medical Devices - Irvine, United States - Compunnel
Description
Key Points:
Key Responsibilities:
Test, and/or improve products by developing moderately complex experiments and tests (including writing and executing protocols), analyze results, make recommendations, and develop reports, based on engineering principlesGenerate work instructions, test methods, engineering drawings/prototypes, etc.
to establish/characterize product and/or process specificationsCreate/update portions of design control documents including requirement specs and risk documentsAssign R&D support tasks; gives instruction to technicians on conducting tests; train technicians and provide feedback; and coordinate technician workIdentify, evaluate, manage, and provide guidance to suppliers, including establishing tolerances and defining acceptance criteria for suppliersLevel of Independence: