* Responsible for inventory management and customer satisfaction * Responsible for labor productivity and efficiency, employee retention, adherence to labor contract, and employee relations * Provides training and daily guidance, maintain operating procedures, and update training materials, and ensure personnel training requirement/documentation are current * Ensure operating permits, rules and regulations are complied with * Prepare and facilitate plant-wide safety meeting * Ensure safety procedure adherence establishing a proactive safety culture within the production unit * Provide safety leadership and be a safety culture role model for 24/7 operating unit personnel Strong leadership and inter-personal skills are essential. Strong troubleshooting skills are necessary to maintain unit operation. Responsible for safety, production, quality, costs, training, and customer service. Responsible for the day to day operations of a process unit, which is a 24/7 operation, by supervising union wage roll employees. * Application of statistical and analytical methods such as DOE highly desired. * Demonstrated experience of process development, capability, optimization and validation. * Manufacturing or process experience in one or more of the following highly desired: medical device (neuromodulation or catheters), micro-assembly, reflow, laser ablation/welding/marking, machining * Various levels are open ranging from 2-10 years of experience * Bachelor's degree in an Engineering discipline or related technical field required. Available to support and trouble shoot ramp up issues as needed. * Involved in prototyping, process development, confirmation runs, and validation. * Ensure that proper technology processes are developed, implemented maintained, and documented to successfully introduce new products into manufacturing. This knowledge may be leveraged across various technologies as needed. * Utilizes process characterization skills and tools such as Design of Experiments (DOE), pFMEA, scale up factors, mitigation to foreseen risks, and capability analysis. * Provides significant guidance regarding technical strategies and approaches works cross-functionally in identifying, analyzing and resolving technical issues. Assess and incorporate input for design for manufacturing. * Develops processes, fixtures, and equipment for site requirements. * Lead or contribute to design, development, validation activities through product life cycle for complex assemblies in accordance to project scope If you are open to learning more about these direct hire openings please apply to this posting or email * Experience working in a quality management systemĪ client of ours in the north metro has several openings for Process Development Engineers! These roles are within the medical device industry, however medical device experience is not required. * Expertise using SolidWorks to design systems and components and to produce engineering drawings * Successful record designing prototypes, tools, and fixtures * Proven experience working within teams to design and refine medical devices * Ideally targeting 2-6 years of experience within product development * Ensure compliance with company policies and procedures * Generate and protect intellectual property through proper documentation & communication * Team collaboration to achieve project targets and objectives * Build prototypes and fixtures for testing and production * Design injection molded parts, sheet metal components, and complete assemblies * Produce manufacturable drawings and specifications * Interface with end users to understand design requirements This is a direct hire role located in Eden Prairie, MN. The Engineer will deploy and maintain assemblies and components as part of a project team that results in a complete, ready to sell electronics-based surgical navigation product by a) designing new and maintaining existing mechanical designs, b) conducting testing and engineering studies to demonstrate performance, c) producing fixtures and support equipment for production and testing, and d) communicating status and results. The Engineer will select materials and off-the-shelf components, and design solutions incorporating injection molded plastics, sheet metal, and machined components. A medical device start up client of ours is seeking a Product Development Engineer to develop mechanical components and assemblies for a surgical navigation system.
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