Role Overview
We are looking for a System Engineer (Electrical / Electronics) to support manufacturing operations, product transfer, and continuous improvement activities in a regulated manufacturing environment. The role involves close collaboration with production, quality, and engineering teams to ensure product quality, yield targets, and manufacturing readiness.
Key Responsibilities
Manufacturing & Product Support
- Support product transfer of new and existing products from overseas manufacturing sites
- Set up production lines, perform line balancing, and conduct operator training
- Achieve and sustain manufacturing first-pass yield targets
- Review product designs for manufacturability, availability, and quality
- Support New Product Introduction (NPI) and product transfer activities
Engineering Change & Quality Management
- Manage Engineering Change Requests / Orders (ECR/ECO) and product qualifications
- Perform failure analysis and implement corrective and preventive actions
- Review and disposition customer returns
- Create and maintain Bills of Materials (BOMs)
- Define and maintain procedures, work instructions, and technical documentation
Process Improvement & Maintenance
- Drive continuous process improvement initiatives
- Apply Lean Manufacturing, Six Sigma, and 5S methodologies
- Support preventive maintenance and calibration activities
- Ensure compliance with ISO 13485 and risk management requirements (pFMEA)
Qualifications & Experience
- Degree in Electrical or Electronic Engineering
- Minimum 3–5 years of experience in a discrete manufacturing environment
- Preferably within Life Sciences or Medical Device industries
- Proven accountability for manufacturing yield targets and line uptime
- 3+ years of experience in:
- Electrical and electronic components
- Engineering change management (ECR/ECO)
- BOM creation and maintenance
- Strong knowledge of:
- ISO 13485, risk management, pFMEA
- Manufacturing processes such as PCBA, wire harnesses, cables, connectors, and power supplies
- Ability to read and interpret electrical drawings and schematics
Key Competencies
- Strong problem-solving and analytical skills
- Excellent communication, interpersonal, and teamwork abilities
- Good planning, organization, and time management skills
- Ability to work under pressure and meet tight deadlines
- Proven ability to work effectively in cross-functional teams