Chicago Area, IL
Permanent Position
Description for Principal Systems
Engineer: Seeking Principal Systems Engineer. In this role,
you must be able to:
- lead
projects as R&D Core Team member / Lead Systems Engineer
- write
Use Cases, System Requirements, and Risk Management for high volume single
use medical devices
- monitor
and drive down technical risks
- work
closely with Global Marketing teams to translate user needs and VOC into
engineering concepts, architectures, and system requirements and solutions
Responsibilities for Principal
Systems Engineer:
- Analyze,
evaluate and plan methods for the solution of complex problems.
- Conduct
investigations of considerable complexity pertaining to the development of
new designs, methods, materials or processes, and investigate possible
applications of the results.
- Develop
project direction together with management.
- Accept
the highest level of accountability.
- Plan
and direct major technical phases of projects.
- Provide
technical direction and coordinates team efforts.
- May
be responsible for directing assigned engineering and support staff.
- Apply
advanced theories and concepts.
- Optimize
solutions from a systems point of view by taking into account the effect
of any change on other parts of the systems and supporting functions.
- Design/modify
complex systems.
- Design/modify
complex/high-level systems architecture requiring multidisciplinary
expertise or in-depth knowledge in a single discipline; defines parameters
and boundaries for lower-level design activities.
- Establish
error budgets for key aspects of system performance.
- Integrate
multiple project plans.
- Establish
and review complex plans for multiple activities/projects or plan highly
complex personal projects.
- Work
closely with Global Marketing, Engineering, Medical, Regulatory, and
Quality to take the system from concept through FDA approval to field
deployment.
Requirements for Principal Systems
Engineer:
- 10+
years experience with Bachelor’s degree, 4+ years experience with Master’s
degree, or 3+ years experience with Ph.D.
- 5+
years experience in systems engineering for medical devices
- Experience
with drug delivery therapies and infusion technology
- Experience
with associated consumables of infusion technology
- Experience
with medical product submissions to FDA/501K; hazard & reliability
analysis
- Experience
with system modeling/simulation, architecture, requirements development
and structured analysis
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