Systems Engineering 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:

Lead the systems engineering department in support of our KMC Systems business unit, providing both technical, process and people leadership to this strategically critical function. You will be responsible for leading and managing the engineering and related support personnel involved in the design and development of these products. You will assist in the development of proposals, programs plans and execution major customer and internal engineering programs.

PRINCIPAL RESPONSIBILITIES

· Working with program management and other engineering disciplines, plan and execute major research and development programs based on long range business goals.

· Define and execute systems engineering department organizational development strategies to yield a “best in class” systems engineering team which meets the business needs of:
- Operational analysis
- Requirements management
- Application of best practices in design, analysis, simulation, integration & test
- Application of best practices in Design Controls, Product Lifecycle Management, Configuration Management, Phase Reviews

· Establish procedures and assignments to be followed to meet program completion dates as planned; ensure that estimates of manpower needs, costs and budgets are prepared, established and monitored; review and evaluate progress of subordinate activities.

· Direct initial program planning including proposal philosophy coordination, technical baseline definition, proposal preparation; subcontractor statements of work specifications; estimation of product or service costs.

· Direct others who devise applications of engineering technology to solve problems.

· Assure that product designs are competitive.

· Evaluate and select optimum design alternatives.

· Define projects and act as technical leader, assisting others in the solution of complex problems involving diverse areas of various technical disciplines.

· Determine technical and cost feasibility of projects; prepare proposals for new business with assistance from subordinates.

· Serve as consultant to top management in establishing long range goals and preparing proposals for new business.

· Act as spokesman to customer personnel on engineering capabilities and future efforts. May be instrumental in attracting and obtaining major new business contracts.

· Assure engineering research and development results are consistent with customer and company requirements and objectives.

· Assure effective liaison with other functions and departments to obtain all cooperation and support required for the success of assigned programs.

· Review job performance of subordinates and personnel assigned to program; ensure assignments are given according to individual capabilities and promotions, transfers, terminations, compensation change are acted upon where warranted. Responsible for developing and utilizing talents of assigned personnel to best accomplish company goals.

Qualifications:

A Bachelor’s degree in engineering or physics, Masters preferred, and 12 or more years of directly related experience to be proficient in the above areas.

o Requires experience in the design and development of medical device systems or other FDA regulated products.

o Must have experience managing the white space between multiple engineering disciplines. Must have experience in the application and limitations of applying state of the art CAD tools, PLM and CM tools and a proven track record of accelerating time to market.

PLEASE APPLY DIRECTLY ONLINE AT:

https://jobs-esa.icims.com/jobs/3004/job

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