Printed Circuit Board Design Engineer

Role : PCB Design & testing Engineer

Location

Boston, MA - onsite

Keywords

PCB Design & testing ,PCBA (Analog, Digital and Mixed Signal) right from schematic to Layout file generation

Component engineering. Root cause analysis, FEMA for electrical design.

Electrical & Electronics Components ,Knowledge in CAPA execution

Knowledge in Computer System Validation activities is added advantage ,Good Knowledge in Medical Hardware Development Life Cycle (HDLC)

Good Knowledge in Requirement Tracematrix preparation

Education : only electrical engineering degree

JD :

HCL to support Supplier Quality Engineering team for the below activities.

Knowledge in Electrical Components

Knowledge in Medical Domain

NCs (Non-Conformance)

Process Verification Engineering (PVE).

Engineering support for the following activities.

IQ/OQ/PQ.

Test Method Validations.

Master Validation Plans.

Process Characterizations

Review and approve key quality records related to JJMD products in accordance with the Quality Agreement (QA) and Quality System Execution Plan (QSEP) as per Change Control process.

Reviews high-risk CAPAs (i.e., Field Action, Critical Audit Observations, Major External Audit Observations, Near Misses and PRM).

Partners with the SC to assess nonconformances resulting from the product release monitoring (PRM) process.

Supports SC Quality and Manufacturing Engineering on the resolution of Quality issues impacting JJMD products and coordinates additional subject matter expert support needed from JJMD.

Supports SC on External Audit Readiness initiatives.

Risk Assessment process (ISO 14971) and UFMEA, PFMEA, DFMEA and SFMEA process

Mechanical, Electrical Drawings reviews

Design Transfer Inspection Requirement (DTIR) preparation based on Risk files assessment