Electrical Engineer : Plano , TX - Georgia IT Inc.

Plano, TX

About the Job

Electrical Engineer : Plano , TX
Rate : $ DOE ( Locals Preferred )
Duration : Long-term Contract.

Electrical Engineer with product development and system engineering experience in Medical Device industry who can fit into compliance, Supplier change request, end-of-life component work.

· Electrical Engineer to support EUMDR/Supplier Change Request/End Of Life
· Electrical Engineer with compliance and strong manufacturing background
· Systems engineering experience in front end (requirements management & risk management)
· Product development experience is required to do supplier change request & end-of-life work.
· Compliance experience in IEC 60601 (requirements for basic safety and essential performance for Medical Equipment)

Detailed JD:

Provide technical expertise in support of unplanned production issues (EOL, NCMR, Supplier Corrections)
Support design documentation preparation and review for market expansions
Run empirical and experimental analysis.
Resolve and/or facilitate resolution of problems including identifying causes to prevent re-occurrence (CAPA).
Solve complex problems using hardware engineering knowledge and engineering best practices.
Work cross functionally to determine the optimal course of action including impact to existing submissions and compliance certifications.
Work with outside consultants, vendors, and the medical community.
Ensure requirements of Design Controls are followed.
Ensure that the quality system requirements are being met.
Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

5+ years of relevant product sustainment or R&D experience in the medical device industry.
Bachelor's degree in Electrical or equivalent. Master's degree in Engineering preferred.
Experience providing ongoing sustaining technical support to a manufacturing organization.
Knowledge of medical device design controls and project management.
Demonstrated knowledge of risk management techniques.
Demonstrated knowledge of requirements development.
Demonstrated knowledge of CAPA process and root cause investigation.
Knowledge of statistical techniques and design of experiments.
Experience with designing and testing medical devices.
Strong Experience with schematic and PCB layout design and simulation tools (Altium etc).
Understanding of PCB assembly processes
Experience working in a broader enterprise/cross division business unit model preferred.
Ability to work in a highly matrixed and geographically diverse business environment.
Ability to work effectively within a team in a fast-paced changing environment.
Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization
Strong organizational, planning, and follow-up skills and ability to hold others accountable.
Ability to travel approximately 30%.
Ability to maintain regular and predictable attendance.

Source : Georgia IT Inc.