KMC Systems, a wholly-owned subsidiary of and co-located with 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 30 years of experience, KMC is an ISO 13485 certified and FDA registered firm with expertise in all aspects of medical product development, verification, design for and transition to production. Additional capabilities include flexible turnkey manufacturing, depot repair and full compliance with FDA QSR regulations and GMP practices.
Elbit Systems of America is a leading provider of high performance products, system solutions, and support services focusing on the defense, homeland security, commercial aviation, and medical instrumentation markets. With facilities throughout the United States, Elbit Systems of America is dedicated to supporting those who contribute daily to the safety and security of the United States. Elbit Systems of America, LLC is wholly owned by Elbit Systems Ltd. (NASDAQ: ESLT and TASE: ESLT), a global high technology company engaged in a wide range of programs for innovative defense and commercial applications. For additional information, visit: www.elbitsystems-us.com or follow us on Twitter.
As Manager of SW Quality Engineering, you will manage software quality assurance resources and activities; review and approve software documentation for development and/ or manufacturing programs where KMC has software development or test engagement, and perform quality assurance testing across product specific and non-product specific software within KMC Systems. You will maintain process, procedures and tools related to software development and software testing, ensuring that performance and quality of products conforms to established company and regulatory standards, and customer requirements and specifications.
Assure efficient, cost‑effective and timely design and implementation of software verification and validation plans and procedures for inspecting, testing, and evaluating the assigned product lines to assure their compliance to specifications and regulatory requirements.
Approve the final release of product software.
Ensure implementation of applicable software procedures and practices within KMC Systems’ Quality Management System to support the success of internal, regulatory, and customer requirements/audits.
Provide effective liaison and direct interface with both internal and external customers to resolve questions or problems concerning matters of software quality assurance.
Develop the preparation of labor estimates on proposals or in‑house design efforts.
Review and/or direct defect and failure analysis activities.
Conduct method/process improvement in conjunction with Software Engineering.
Educate as needed external and internal customers on the requirements of software development and software testing for regulated versus non-regulated software.
Create and maintain detailed software quality Assurance schedules for program task tracking.
Participate in software planning, requirements, architecture, design, and risk analysis activities and reviews.
Conduct or direct software audits of internal and external software programs.
Review job performance of subordinates and ensure assignments are given according to individual capabilities. Responsible for developing and utilizing talents of assigned personnel to best accomplish company goals.
Position reports to: Executive Director of Engineering, KMC Systems
Bachelors degree and 10+ years’ experience in software development and/or testing of software; 3+ years of hands on engineering leadership managing a QA team involved in both manual and automated testing
Knowledge/experience in object oriented languages (C#/Java/C++)
Knowledge/experience in common Operating Systems (Linux/Windows)
Proven knowledge/use of DOORs, defect tracking tools, requirements tracing and source control management systems
Skilled in MS programs such as Excel, Word, PowerPoint, Project, and Visio
Able to work in a fast-paced, independent and team-based environment.
Must be a detail-oriented individual with solid organizational skills.
Able to communicate well with both technical and non-technical people
Knowledge of Risk Management and Risk Analysis process.
Strong understanding of medical device quality assurance processes and methodologies in a software development, IEC 62304 / ISO14971 / 13485, environment
Understanding of the Software Development Life Cycle.
Strong experience with a version control system (i.e. CVS), Defect-tracking and automated testing tools.
Demonstrated experience working in a Scrum/Agile environment.
Experience with test management and automation tools, technologies such as TestRail, Selenium or equivalent frameworks/tools, and test script development practices.
Deep understanding of automated testing techniques for full stack testing (from User interface to embedded firmware)