USA_Engineer

Pay Rate Range: $ 38.75 - 45.45/hr.

GBaMS ReqID: 10389662

Job Description:

Lead electrical engineering activities for sustaining and legacy medical device products.

Investigate and resolve electrical component obsolescence, supplier changes, and field issues.

Perform root cause analysis and implement corrective and preventive actions (CAPA).

Support design changes, verification validation, and documentation updates in compliance with FDA, ISO 13485, and IEC 60601 standards.

Collaborate with cross-functional teams to ensure timely resolution of product issues and implementation of design improvements.

Participate in risk assessments (FMEA), design reviews, and change control processes.

Provide technical support for manufacturing, test engineering, and quality assurance teams.

Maintain and update technical documentation including schematics, BOMs, test protocols, and reports.

Ensure compliance with regulatory requirements and internal quality systems.

IEC 60601, ISO 13485, FDA 21 CFR Part 820, Circuit Design, PCB Layout, Embedded Systems, MATLAB LabVIEW, Sensors, Drivers, Microcontroller, Electrical Testing, DHF DMR, Risk Management (FMEA), CAPA, Sustenance Engineering, Design Control

Skills:

Category Name Required Importance Experience

SkillCategoryTest1_MN EIS : Embedded Digital Hardware Design and Development Yes 1 7+ years

SkillCategoryTest1_MN EIS : Medical Device & Regulations Yes 1 7+ years