Senior Systems Engineer-Complex Electromechanical Medical Device Systems

Job Summary:

At HiARC, Systems Engineers provide leadership for small to mid-sized cross-functional program teams to deliver the technical content, performance, intellectual property and quality deliverables for new product development programs.

Drives the architecture, vision and design requirements for the product all the time balancing implementation complexity, risks, manufacturability, serviceability and quality.

The Systems Engineer must understand and capture the user needs into system requirements.

The System Engineer helps to ensure that the quality targets are satisfied and retires technical risks as they arise on the program.

The Systems Engineer maintains close interaction with customers to understand and enhance the ability to deliver customer satisfaction through higher product quality.

Under close guidance and supervision, apply basic engineering and scientific principles and techniques to assist in the development and establishment of quality assurance programs which provide and maintain the highest quality levels for an assigned project, product, or area.

Responsibilities:


* Lead effort to create system level concepts for new project proposals.

Review and critique concepts created by others


* Ability to prepare Systems Engineering cost and schedule estimates on major design development efforts.

Provide technical presentation support and consultation to marketing for proposals and during development.


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

Translate experimental results into design criteria.


* Support System Integration, Verification and Validation by defining, specifying and supervising testing, analysis and integration activities.

Ensure reports are prepared to document the results of such activities.


* Support the design review and phase gate process to ensure that engineering deliverables are at the appropriate level to meet FDA/ISO requirements & standards.


* Accountable to oversee the development of requirements for different disciplines such as Software, Electrical, Mechanical, Electro-optics and others.

Qualifications:


* Required:
+ Bachelor's degree in engineering
+ 5 or more years of complex electro-mechanical instrument systems engineering experience, to include
+ experience integrating hardware and software


* Preferred, but not required:



* Master's degree in engineering


* Medical Device experience (FDA or other regulated design environment)


* Extensive development experience in at least one or more of the following engineering disciplines is required: software, mechanical, electrical, optics, fluidics and should possess knowledge of advanced theories, concepts, principles, and processes.


* Ability to provide technical leadership as required during the investigation of complex medical instrumentation products.

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