Principal Systems Engineer- 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:

· Responsible for creating and interpreting medical device desired feature/functions into product requirement specifications. You will generate instrument system, hardware and software requirements in compliance with FDA Design Control regulations as well as conduct tradeoff analyses, risk analyses, FMEA and prepare system level design specifications including interface definition.

· Provide technical and managerial leadership over complex, major design, development and research projects.

· Prepare project requests detailing proposed engineering work costs and product timetable.

· Provide technical presentation support and consultation to marketing.

· Represent company unit in customer or field force contacts.

· Recommend the addition, expansion or termination of research projects and assure the technical soundness of engineering programs.

· Evaluate and select optimum design alternatives. Lead effort to create system level concepts for new products, review and critique concepts created by others.

· Prepare cost estimates on proposed major design products.

· Plan and lead experiments to evaluate operating characteristics of products or processes.

· Produce innovative technical solutions to customer’s problems.

· Prepare technical proposals for competitive bids.

· Research information on equipment and cost for project proposals.

· Perform preliminary engineering necessary to confirm plans and programs.

· Develop potential applications to exploit new business opportunities.

· Collect and analyze information on competitor product performance.

· Initiate and conduct field testing and research work for new applications.

· Translate experimental results into design criteria.

· Provide application engineering to customers.

· On a project or on-going basis, supervise the work of other engineering personnel.

· Utilize project planning and monitoring methods to ensure timely completion and communicate project status to appropriate departments.

· Assist in developing engineering budgets.

· Review and approve completed design work.

· Mentor and guide junior System Engineers.

· In charge of requirements development and management. Oversee the development of requirements of different disciplines such as Software, Electrical, Mechanical, Electro-optics and others. Verify and approve all requirements.

· Perform and verify system level analysis such as system safety, reliability, failure modes, etc.

· Support System Integration, Verification, Validation and Certification by defining, specifying and supervising testing, analysis, Installation and integration activities and preparing reports to document the results of such activities.

· Identify, prioritize and implement new development capabilities that decrease time to market, development cost, product cost, development quality and product quality.

· Support the design review and phase review process to ensure that engineering deliverables are at the appropriate level of completes and quality.

· Act as the focal point and center of competence for current/future regulatory requirements. Ensure that the program plans support the appropriate level of regulatory compliance based on product application.

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/2984/job

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