|Date Posted||July 22, 2021|
Recognized global leader in development and manufacturing of cutting edge technology in diagnostic instrumentation has immediate need for Automation Engineer. Role responsibilities:Automation Engineer will be responsible for leading process engineering projects with a primary focus on robotics and automation. Partner with Product Development, Product Transfer Support and Manufacturing to identify and thoroughly define user requirements for semi and fully automated systems. Lead the development, procurement, installation and validation activities for new automated systems. Key activities will involve analysis of the current manufacturing process, identifying areas where automation will significantly reduce labor cost and/or improve product quality and partner with equipment vendors and system integrators to develop solutions. This position will be instrumental in developing and executing a plan to meet GenMark s gross margin short and long-term goals.Additional responsibilities: Lead project teams as part of product improvements, automation, and quality improvementsContinuously Improve production processes in manufacturingTroubleshoot issues that arise within the manufacturing processApply various tools (example DOE) to evaluate production capacities and capabilitiesApply standard project management tools and principles to ensure project successServe as advocate and role model for integrating change into the organization as well as serve as departmental role model of professional behavior and presence.Lead change control activities within cross functional departmentsCreate and approve Product BOM s, Specs, Work Instructions and other documentation as part of the Design Transfer for new product introductions.Follow cGMP and ISO standardsPreferred qualifications Bachelor s or advanced degree in a mechanical, chemical or relevant engineering field with 5 years of experience in the healthcare/biotech/pharmaceutical industry preferredExperience in defining user requirements and implementing robotic systems or automation equipmentChemical Familiarity with multi-step organic chemical purification.Experience with evaluating and transferring molded plastic components, PCBs and other consumables into manufacturing environments.Problem Solving Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions.In-depth experience with process and product validations, specification setting and test method validations, statistical process control techniques and FDA design control documentation is required.Project Management successes with expertise influencing key decision makers within a matrix environmentWorking knowledge of pharmaceutical/medical device cGMPs and FDA compliance is strongly preferredStrong quality-orientation with attention to detail and a desire to deliver service excellence is essentialExperience with design transfer activities for medical devices in international markets is a plus.Strong influencing and interpersonal skills and the ability to work well with others in a proactive, positive and constructive manner.