System Engineer

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.

• 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.

• 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: ISO 13485 and quality management systems;
  Risk management and pFMEA;
  Lean Manufacturing, Six Sigma, and 5S.
• Hands-on understanding of manufacturing processes such as: PCBA;
  Wire harnesses and cables;
  Connectors and power supplies.
• Ability to read and interpret electrical drawings and schematics.
• Demonstrated experience in New Product Introduction (NPI) and Product Transfer.