System Engineer with Medical Device Experience NEEDED (contract position)
Lisa Risley
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.
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.