Senior Manufacturing Engineer

Job ***** Sr Engineering ***** 6 Months Contract with possible extension ***** Irvine, CA Job ***** Create, 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 principlesDriving process and equipment validations (ex. TFIQ, IQ, OQ, PQ).Drafting, approving, executing, and maintaining all relevant documentation (ex. SOPs, operator training, specifications, drawings, process sheets, FMEAs, and validation plans).Create/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 suppliersOther duties assigned by Leadership**Bachelor's degree in engineering or Scientific field & 4+ years experience -OR- Masters Degree or equivalent in Engineering or Scientific field & 3+ years experienceCAD experience (Solidworks -or- Creo)Statistical based software (Minitab, JMP)**Medical Device experience strongly preferredExperience in test method development including Fixture development and ValidationBasic understanding of statistical techniquesDevelop, update, and maintain technical content of risk management filesUnderstanding and knowledge of principles, theories, and concepts relevant to EngineeringSolid problem-solving, organizational, analytical and critical thinking skillsGood documentation, communication (e.g., written and verbal) and interpersonal relationship skills including consultative and relationship management skillsAbility to interact professionally with all organizational levelsAbility to manage competing priorities in a fast paced environmentAbility to build productive internal/external working relationships

Created: 2025-02-19