Manufacturing Engineer II

1 week ago

Draper, United States TalentBurst Full time

Position: Manufacturing Engineer II,Req#: 7286-1Location: Draper, UT (100% onsite)Duration: 6+ Months ContractJob Description:Applies knowledge of technical principles and the client's systems/procedures to introduce new products into commercial production and optimize manufacturing processes.What does this group do? Development, introduction, validation, and commercialization of new products.Specific technology/software used? Experience in another medical device company would probably encompass systems somewhat similar to what we use, such as Camstar Manufacturing Execution System, Ignite PLM system, Maximo calibration and maintenance system, etc. A typical workday look like? Planning and coordinating builds cross-functionally, providing on-the-floor build support and operator training, sharing feedback from the floor with the NPD team in Irvine, and helping setup equipment and coordinating line changeover Updating equipment in the Maximo calibration and maintenance system, performing an IQ on new equipment. Redlining and updating manufacturing and inspection procedures Creating and updating other DMR (Device Master Record) documents, such as routers, BOMs, SOPs, etc. Executing design verification and process validation buildsWhat will the work schedule be? Can any overtime be expected? 8 hours/day, 5 days/week. Hours are somewhat flexible, but mostly between 9 am-5 pm. Some flexibility for earlier hours is needed when supporting builds with the operations team (1st shift production I believe is about 6 am to 4 pm). Occasional overtime can be expected.Will there be any travel involved? Minimal to none (< 10%)What are your top 3 required technical skills? Must haves? Good communication and organization skills Ability to learn and use production systems (calibration and maintenance Maximo system, MES (manufacturing execution system), and Ignite PLM system) Good problem-solving skillsEducation and Experience: Bachelor's Degree in Engineering or Scientific field with 2 years of industry experience OR Master's Degree in Engineering or Scientific field with 1 year of industry experience requiredQualifications and Additional Skills: Strong verbal/written communication and interpersonal skills Basic understanding of statistical techniques Previous experience working with lab/industrial equipment or manufacturing support role Substantial understanding and knowledge of principles, theories, and concepts relevant to Engineering Strong problem-solving, organizational, analytical and critical thinking skills Substantial understanding of processes and equipment used in assigned work Strict attention to detail Ability to manage competing priorities in a fast-paced environment Ability to work well independently as well as part of a team Good leadership skills and ability to influence change Ability to interact professionally with all organizational levels Knowledge of and adherence to the client's Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing Knowledge of applicable FDA regulations for the medical device industry Adhere to all company rules and requirements and take adequate control measures in preventing injuries to themselves and others as well as to the protection of the environment and prevention of pollution under their span of influence/controlKey Responsibilities: Identify and ensure implementation of opportunities to optimize/improve manufacturing processes including using engineering methods (e.g., SIX Sigma and LEAN methods) employing technical design skills to re-design/design of and ensure equipment, tools, fixtures, etc are up to standards Oversee the planning/preparation, execution, and documentation of engineering builds. Develop experiments and tests (including writing and executing protocols) to qualify and validate manufacturing processes and equipment; analyze results, make recommendations, and develop reports Analyze and resolve Manufacturing and Compliance issues (e.g., CAPA, non-conformances, audit observations) Develop training and documentation materials (e.g., work instructions) for production to enable the seamless knowledge transfer of project and manufacturing processes Support establishing project plans to ensure deliverables are completed to customer's expectations Oversee manufacturing support tasks; give instruction to technicians on conducting tests; train technicians and provide feedback; and coordinate technician work Other incidental duties assigned by LeadershipTB_EN

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