Job Description

·      We are seeking an experienced System Engineer - Electrical Engineer to support product transfer, new product introduction (NPI), and continuous improvement activities in a discrete manufacturing environment.

·       The role will focus on production line setup, yield improvement, engineering change management, and compliance with quality and regulatory standards, particularly within Life Sciences or Medical Device manufacturing.

 Key Responsibilities 

·      Lead product transfer activities for new and existing products from overseas manufacturing sites.

·       Set up and optimize production lines, including line balancing, process validation, and operator training.

·       Achieve and sustain Manufacturing First Pass Yield (FPY) and overall production performance targets.

·       Manage and execute Engineering Change Requests (ECR/ECO), including qualification and implementation.

·       Drive continuous process improvement projects using Lean, Six Sigma, and 5S methodologies.

·       Perform failure analysis and implement effective corrective and preventive actions (CAPA).

·       Define, maintain, and improve manufacturing procedures, work instructions, and technical documentation.

·       Oversee preventive maintenance and calibration programs for manufacturing equipment.

·       Review and disposition customer returns, identifying root causes and improvement actions.

·       Collaborate with cross-functional teams to ensure Design for Manufacturability (DFM), availability, reliability, and product quality.

·       Support Bill of Materials (BOM) creation, updates, and lifecycle management. 

·      Ensure compliance with ISO 13485, risk management practices, and regulatory requirements.

 Qualifications & Experience

·       Bachelor’s degree in Electrical or Electronic Engineering (or equivalent).

·       3–5 years of hands-on experience in a discrete manufacturing environment, preferably in Life Sciences or Medical Device industries.

·       Proven accountability for manufacturing yield, downtime reduction, and line performance across multiple product lines. 

·      3+ years of experience working with electrical and electronic components.

·       3+ years of experience managing Engineering Change Requests/Orders (ECR/ECO). 

·      3+ years of experience in BOM creation and maintenance.

·       Strong knowledge of: 1.ISO 13485 and quality management systems 2.Risk management and pFMEA 3.Lean Manufacturing, Six Sigma, and 5S 

·      Hands-on understanding of manufacturing processes such as: 1.PCBA 2.Wire harnesses and cables 3.Connectors and power supplies

·      Ability to read and interpret electrical drawings and schematics.

·       Demonstrated experience in New Product Introduction (NPI) and Product Transfer.