Principal Systems Engineer-Hardware- Medical Device Development

This is an advanced level individual contributor position responsible for solving a variety of technical problems of considerable complexity.

Plans, conducts, and technically directs projects or phases of significant projects, coordinating the efforts of technical support staff in the performance of assigned projects.

May provide technical consultation to other organizations, work leadership of lower level employees, and make recommendations to management of a technical nature.

Must have advanced knowledge of accepted principles and techniques within the systems engineering discipline

Responsibilities:


* Solve a variety of engineering problems involved in the design and development of products, equipment, or processes.

May design and layout complex items.

Consults with higher level engineering personnel to resolve more complex design alternatives.



* Develop specifications against which designs can be produced.

Translates experimental results into design criteria.



* Assist with portions of engineering projects or programs, the formulation of design criteria, or performing analysis of engineering data to select the best technical approach.

Specifies phases of tests, investigation or analysis.



* Assist manufacturing in transition from development into production.



* Determine appropriate materials and processes for specific applications.



* Prepare engineering specifications for purchases.



* Fabricate engineering approval models and prototypes.



* Conduct field testing and research work for new applications.



* Assist in preparing cost estimates on proposed major design products.



* Ensure that sound scientific principles are applied in laboratory or pilot plant work.



* May assist in troubleshooting customer application problems.



* Provide direction to technicians.



* Develop reliability models for electromechanical, electro-optical sub-assemblies and assemblies.



* Ensure component reliability based on technical evaluation of vendor's designs and manufacturing processes.



* Lead 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.



* Perform other related duties as assigned.

Qualifications:


* Bachelor's Degree in engineering or equivalent scientific discipline with 8 or more years of experience to be proficient in the above areas.

Incumbents should possess a broad knowledge of precedents in their area of technical specialization and a good basic knowledge of principles and practices in related specifications.



* Experience in an FDA-regulated environment is essential



* Advanced DOORS requirements management training



* Systems Engineering Simulation and Modeling concepts



* Systems Engineering methods and procedures

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