Senior Program Manager- Medical Devices

US-NH-Merrimack
3 weeks ago
Job ID
2017-5796
# Positions
1
Experience (Years)
10
Priority
High
SECURITY CLEARANCE
NONE

Overview

The Senior Program Manager 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. Sr. PM's are assigned the largest customers or most complex development programs. The Senior Program Manager oversees the development team and interacts with representatives from the quality, manufacturing, procurement, marketing and finance departments. He/she acts as 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.

 

Responsibilities

  • 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 major 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.

 

 

Qualifications

  • Bachelor’s degree in engineering discipline
  • 8 – 12 years of related experience; or an equivalent combination of education and experience
  • 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

 

******************

 

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 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.

 

Elbit Systems of America is an Equal Opportunity Employer

Minorities/Females/Veterans/Individuals with Disabilities

 

 

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