Chicago Area, IL
1 yr. contract
Seeking Systems Engineers for contract position. These are
12 month remediation projects for medical devices.
Requirements & Responsibilities for Systems Engineer:
- Minimum 5 years Medical Devices industry background
- Strong skills in structured investigations consisting of:
- Problem
definition & refinement of problem statement
- Assessment
& technical interpretation of related complaint information.
- Identification
of applicable requirements & associated test methods / results.
- Identification
of testable hypotheses (possible causes) for the problem statement.
Organize & prioritize hypotheses.
- Rule
in /Rule out assessment of identified hypotheses / potential causes using
the following possible approaches:
- Preparation
of objective evidence so support root cause conclusions
- Conducting
technical reviews
- Identification
of possible corrective actions
- Preparation
of formal recommended action summaries.
- Working
knowledge of the FDA Quality System Regulations and how they are applied
to the medical device industry
- Familiarity
with risk management under ISO 14971, including
- Conducting
risk assessments and generating updates to the hazard analysis,
- Tracing
mitigations to requirements and
- Conducting
tradeoff to optimize the risk profile.
-Experience with the development and/or controlled modification
of device Design History Files (DHF) for medical devices including:
- Creating
the Requirements Management Plan document
- Creating
content of all Design Input Documents (DID)
- Creating
tracing at all levels of the requirements flow down
- Creating
allocation of DID to subsystem level specifications
- Reviews
content of subsystem level specifications
- Chief
content provider for the Design Inputs Review milestone
- Generation
of the master trace matrix document
- Experience conducting complaint investigations including
historical analysis & trending
- Experience with complex electro-mechanical devices w/ embedded
software required.
- Experience in leading the system verification and validation
efforts, including the planning and execution of system level tests.
- BS in Electrical / Mechanical / Software / Systems
Engineering required, MS preferred.
- 5 or more years of Systems Engineering /Software Design
experience.
- Working knowledge of Microsoft office products; working
knowledge of Telelogic DOORs desired.
- Preferred:
Fluid delivery and/ or infusion pumps experience.
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