KMC Systems is a cutting-edge design Services Company focused on solving complex engineering problems for medical OEMs and start-up companies using multidisciplinary expertise, collaborative teams, and proven processes.  We have contract designed a broad range of medical devices and instruments ranging from clinical chemistry and immunoassay analyzers to minimally invasive biopsy systems and blood incubators.  We currently have an opening for a Senior Mechanical Engineer to join our rapidly growing team. The successful Applicant will work within the engineering department contributing to the design and development of mechanical systems and be part of a focused team creating and supporting new products.

The Sr. Program Manager -Medical Device has full responsibility for the management and overall success of instrument development programs for the medical device market. This encompasses direction of a disciplined engineering team, monitoring and reporting all aspects of program performance with authority to make decisions to assure the success of the project from inception to completion. This position involves the application of complex electronics, optics, mechanisms and software in the development of advanced medical instruments. The Program Manager oversee the development team and interact with representatives from the quality, manufacturing, procurement, marketing and finance departments. You would be the primary point of contact with the customer to assure customer satisfaction as it pertains to project schedules, product technical performance and program / product costs.

• Act as the principal point of contact with the customer, responsible for assuring customer satisfaction in terms of communication; program schedule; program budget; product performance, product cost, and other related information and deliverables.
• Act as principal point of contact with senior management to assure management understanding of the state of the program, appropriate teamwork, adequate resources, reports and program status.
• Foster the resolution of complex problems and coordinate efforts among all management discipline as necessary to assure corrective action.
• Responsible for supporting business development activities: proposal preparation; program planning; statements of work specifications; estimation of product and/or service cost; program requirements; establishment of cost controls and budgets, and the monitoring, reporting and justification of costs.
• Establish, monitor and report adherence to program plans, schedules and costs, prepare and issue operational and program directives and control product configuration.
• Develop and maintain appropriate customer contacts for the strategic expansion of the business within the technical scope of the program through the support of related business opportunities. Coordinate with marketing personnel as appropriate and assist in the preparation and implementation of marketing plans.
• Define and direct the performance of program functional task elements such as procurement, manufacturing, quality, configuration, logistics, administrative functions, contracts administration, facilities, sales, etc.
• Review and approve all contract changes with special attention paid to cost, schedule and risk elements and assure the senior management team is aware of program changes.
• Assure effective communication and teamwork among all functional department heads and program functional team members contributing to the program. Develop and inspire program teams to achieve high performance and positive results for customers, KMC and individuals.
• Conduct periodic program status review meetings with major program contributors, report status relative to all aspects of program objectives, and assure resolution of program performance issues.
• Participate in formulating plans and objectives for the program area and generally review and approve projects and their implementation within the various functional areas.
• Assure the successful product transition to manufacturing and field service support to the customer as required.

• Engineering degree and 5 years of program management experience OR 10 years of direct medical device program management experience.
• Medical device, complex instrumentation, product development/launch/full life cycle or sustainment engineering experience.

Preferred Qualifications:

• PMP Certification
• Experience working in an FDA regulated environment having developed complex medical devices
• Familiar with ISO 13485
• Proven track record of successful program management for complex engineering activities in a dynamic environment
• Familiar with phase gate development approach
• Proficient in Microsoft Project, Excel, Word, database software

As a contractor to the U.S. federal government, all Elbit Systems of America employees are required to be fully vaccinated against COVID-19. As a result, full vaccination is required for this position unless you are legally entitled to an accommodation.

All your information will be kept confidential according to EEO guidelines.