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KMC Systems, a division of Elbit Systems of America, is a leading contract designer and manufacturer of medical devices and instrumentation for OEM’s in the areas of diagnostic, therapeutic, and biomedical products. With more than 40 years of experience, KMC is an ISO 13485 certified and FDA registered firm with expertise in all aspects of product development, verification, design for and transition to production. Additional capabilities include flexible turnkey manufacturing, depot and field service repair and full compliance with FDA QSR regulations and GMP practices.
KMC Systems Engineers provide leadership for small to mid-sized cross-functional program teams to deliver the technical content, performance, intellectual property and quality deliverables for new product development programs. Drives the architecture, vision and design requirements for the product all the time balancing implementation complexity, risks, manufacturability, serviceability and quality. The Systems Engineer must understand and capture the user needs into system requirements. The System Engineer helps to ensure that the quality targets are satisfied and retires technical risks as they arise on the program. The Systems Engineer maintains close interaction with customers to understand and enhance the ability to deliver customer satisfaction through higher product quality.
Lead effort to create system level concepts for new project proposals. Review and critique concepts created by others
Ability to prepare Systems Engineering cost and schedule estimates on major design development efforts. Provide technical presentation support and consultation to marketing for proposals and during development.
Plan and lead experiments to evaluate operating characteristics of products or processes. Translate experimental results into design criteria.
Support System Integration, Verification and Validation by defining, specifying and supervising testing, analysis and integration activities. Ensure reports are prepared to document the results of such activities.
Support the design review and phase gate process to ensure that engineering deliverables are at the appropriate level to meet FDA/ISO requirements & standards.
Accountable to oversee the development of requirements for different disciplines such as Software, Electrical, Mechanical, Electro-optics and others.
Bachelor’s Degree in Engineering
5 years of complex electro-mechanical instrument systems engineering experience
Hardware / software integration experience.
Master’s degree in Engineering.
Medical Device experience
Extensive development experience in at least one or more of the following engineering disciplines is required: software, mechanical, electrical, optics, fluidics and should possess knowledge of advanced theories, concepts, principles, and processes.
Ability to provide technical leadership as required during the investigation of complex medical instrumentation products. Accountable to oversee the development of requirements for different disciplines such as Software, Electrical, Mechanical, Electro-optics and others.