Program Manager- Medical Devices

Company Overview:

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 25 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.

Elbit Systems of America is a world leader in the design and manufacture of avionics flight instruments, technologically sophisticated defense systems and diagnostic medical instrumentation. Elbit Systems of America (ESA) combines the close-knit teamwork and high visibility of a small company with the stability and resources only a large company can provide. Add in our employee-friendly corporate culture and great southern New Hampshire lifestyle, and you’ll see why joining ESA could be the best move of your career.

Position Responsibilities:

You will have full responsibility for the management and success of a major instrument development program for the medical market. This encompasses direction of a disciplined engineering team, monitoring all aspects of program performance and 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 to advanced medical instruments. Oversees a team and interacts with quality, manufacturing, materials, marketing and finance departments. Acts as a point contact with the customer. Assures customer satisfaction on project schedules, instrument technical performance and program cost.

Responsibilities include:

· Act as the principal point of contact with the customer, with responsibility for assuring customer satisfaction in terms of product performance, delivery, cost, and related areas.

· 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 major problems and coordinate efforts among all management disciplines as necessary to assure corrective action.

· Responsible for supporting business development activities: proposal preparation; program planning; statements of work specifications; estimation of product or service cost; program requirements; establishment of cost controls and budgets, and the monitoring, reporting and justifying of costs.

· Establish and monitor adherence to program plans and schedules, preparing and issuing operational and program directives and controlling product configuration.

· Develop and maintain appropriate customer contacts and 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 reach 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 problems.

· 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 successfully transition to manufacturing and satisfactory field service support to customer as required.

Qualifications:

Master's degree in engineering or equivalent scientific discipline and at least 12 yrs of applicable, progressively complex systems engineering experience including hardware/software integration of complex systems. [Or an equivalent level of education and related experience]

Incumbents should possess knowledge of advanced theories, concepts, principles, and processes for one or more areas of technical expertise, and possess creativity and originality sufficient to contribute new inventions, designs or techniques which are of material significance in the solution of important problems.

Extensive development experience in at least one or the following disciplines and limited experience in at least one other is required: mechanical, electrical, optics, fluidics and software.

Knowledge and Training on FDA QSR Design control requirements and or ISO 13485 a plus.

Must have the ability to assess system-level issues of hardware/software tradeoffs, error budgets, reliability and maintainability and verification test approaches.

PLEASE APPLY DIRECTLY ONLINE AT:

https://jobs-esa.icims.com/jobs/3005/job

ELBIT SYSTEMS OF AMERICA IS PROUD TO BE AN EQUAL OPPORTUNITY EMPLOYER