Systems Engineer

Company Name:
Are you a Systems Engineer looking for a new challenging opportunity?
Optomi, in partnership with a cutting-edge medical device organization, is seeking a Systems Engineer for their Lake Zurich,
Why working here is incredible:
- You'll work with cutting edge, lifesaving medical technologies!
- You will also work in a modern, tech-savvy facility
- A giving back mentality - being involved with multiple charitable organizations
Successful candidates responsibilities will include:
Develop system requirements, behavioral and control specifications, and medical device risk management file
Allocate requirements and specifications to elements of the system architecture, and manage requirement hierarchy
Integrate and test system progressively from initial assembly to in-vitro tests with pooled whole blood
Review software and system test procedures and results
Develop and execute protocols for evaluation of device in use with connected donors in Fenwal donor room and external clinical sites
Assist technical writing, clinical education, manufacturing, and field service during commercialization of product
Provide analysis of proposed designs to determine their ability to function as intended by considering use case scenarios and various other inputs.
Develop and maintain detailed documentation, for both internal and external customers, throughout all phases of product development.
Collaborate across organizational functions to achieve company and project objectives; continually improve product performance and capabilities.

Bachelor's degree in engineering (systems, biomedical, software, electrical, or mechanical) and 10 years of increasingly responsible experience in the medical device industry, or
Master's degree in engineering and 5 years of experience in the medical device industry
Knowledge of, and at least 2 years experience in, systems engineering as a defined discipline (e.g., as indicated by the International Council of Systems Engineering INCOSE or by academic institutions with degree offerings in systems engineering).
Experience in compliant practices of design control and medical device risk management
Excellent verbal and written communication skills
Strong leadership and project management skills
Strong analytical and attention to detail
Experience with medical devices in a regulated environment preferred. Experience with apheresis devices preferred.
Ability to operate independently and exercise good judgment.
Experience in writing requirement documents. Experience with Rational software development

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